Welcome back to Signals, a members-only newsletter analyzing key commercial developments across the neurotech industry each month.

Following April’s Acquisition Spree, this edition covers top developments from May 2026, which produced a flurry of commercial milestones across public companies with implanted devices and private startups with non-invasive neuromod, and more in between.

• Mobia’s IPO marks a 19 year, $165M commercial journey

• Medtronic’s $650m SPR Acquisition & Neurmod’s Pain Market

• Inspire’s Updated Guidance & Coding Drama

• Galvani’s Shutdown & Limits of Corporate Innovation

• Oura Takes Two Clinical Steps With New Partnerships

• Neurovalens: 4x FDA = Neuromodulation Platform

• Ampa’s Funding Hints at a Faster TMS Future

• Neurosoft’s Funding & US Expansion Plans

Let’s dive in.

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Representations is a new limited series exploring neurotech’s evolving business frontier. This is produced in partnership with PL Neuro, a project by Protocol Labs. PL Neuro accelerates neurotechnology and neuro AI through field building, strategic investment, and scientific research. Their worldview is deeply technical, yet wholly focused on enabling futures of human flourishing. Over the coming months we’ll explore key topics, trends, and themes, featuring experts from PL Neuro’s ecosystem and market insights from Neurotech Futures’ platform.

Welcome back to Representations. Last month we charted neurotech’s rising tide of leadership, infrastructure, and investability. This built on the business flywheel of data strategies for next-generation implanted neurotechnologies.

Congrats to PLC Neurotech’s newest investment Neurosoft on their oversubscribed $7.5m seed. Adding this to our fundraising tally brings 2026’s year-to-date investments to $658m+ across 25 implanted BCI companies, from 55 investors in over 10 countries, including 20 from China.

Commercialization costs in BCI come down to two categories: people and technology. Today’s leading BCI startups are not just building cutting-edge technology; they are creating conditions that foster successful decision making and attract top talent.

In a word, culture. This edition highlights one of the most popular and important topics in neurotechnology: Working at BCI companies.

On Purpose: Why Motif Neurotech is a One-KPI Company

I caught up with Motif Neurotech’s founder & CEO Jacob Robinson to reflect on the journey to their first-in-human implant for a psychiatric BCI, recently authorized by the FDA and planned for this summer.

You founded Motif Neurotech in 2022, raised a Series A in 2024, won grants from ARIA in the UK and ARPA-H in the U.S., signed new partners and leaders. You’re about to enter the clinical stage. What’s top of mind for you right now?

In Neurotech, we often talk about the devices and the risks, but not the benefits. So as we move towards demonstrating safety in people, I’m thinking about how many people who are struggling now, who just want peace of mind. I hope that we begin to normalize mental health as a biological problem, just like cancer and diabetes, and there’s no more shame in the diagnosis.

Going back to 2022: I had a couple of people, and I had a Slack channel for Motif Neurotech, and our goal was to build something that was going to help affect people’s lives. We developed one KPI, which is days of service. The purpose of the company now is to create days of service for our patients. That number has been zero since 2022. And in a few months, it’s going to go from zero to one, on the day when we implant our first patient.

How does culture drive mission at Motif?

What I realized early on as a founder is that I could not pay people more money than they were making in their corporate job, I could not provide them more security than their corporate job, but I could give them one thing their corporate job might not give them, and that is purpose. When you can build just a small nucleus of people who are motivated by purpose, they attract other amazing people.

The other thing that was really important for us is that I got to know Jen French early on. She really impressed upon me the importance of working with people with lived experience, and so we set up a community advisory board from the beginning. Jon Nelson and Amanda Geisinger shared their journeys at Asilomar last month. Not only does it tell us what the actual users care about most, it keeps us focused on helping people get better.

You just won an ARPA-H grant for Evidence-Based Validation & Innovation for Rapid Therapeutics in Behavioral Health (EVIDENT). What’s that about?

One of the reasons I founded Motif was going to conferences and seeing people try to make sense of brain data from five subjects or 10 subjects, to try to understand something as complex as depression. They’ve done some amazing work with these small data sets, but it made me wonder what would be possible if we didn’t have such an impoverished data set. That’s not how we develop LLMs, right? You don’t train an LLM on, like, five people’s emails, but that’s what we’re trying to do in neurotech in many ways. So EVIDENT is an effort by ARPA-H to address that exact problem: How can we use large data sets to create objective measures and very precise biomarkers of mental health states, so that we are not based on survey scores.

It was 100% aligned with what we wanted to do at Motif from the beginning. What’s really special about the program is that our piece of that is now going to get connected with work from other groups that are measuring things like EEG or proteomics, gut metabolomics, and actigraphy. And so, together we’re going to create this massive multimodal dataset, which will include brain data from the patients who participate in that trial. With that we can finally start to track psychiatric states based not only on what people are communicating with their words, but also with what is actually happening in the brain itself.

You won an ARIA grant in 2024 for Precision Neurotechnologies. This is what seeded your recent partnership with the chip company Mint Neuro, right? Tell us about that program(me) and what makes for a strong commercial partner in neurotech.

The ARIA opportunity was a perfect fit. It’s asking, ‘If the brain is a distributed network, how can we give people an opportunity to regulate that network more effectively?’ That’s the long-term vision of Motif.

And it happened to lead to this partnership with Mint. We knew we needed integrated circuits. We didn’t know where we were going to source them, but Mint was also part of the ARIA grant,so we met them there and they turned out to be fantastic partners for us. I’d say successful strategic partnerships are ones with the right alignment of incentives, so both parties are equally motivated.

It was serendipitous, but my lesson to other folks leaving academia to build startups is that we decided to look for what is already on our roadmap that we can pull forward with grant opportunities. That’s been our North Star.

Follow Motif on LinkedIn for updates on their forthcoming RESONATE trial.
Please consider joining or sharing their patient registry with anyone who might be interested.

On Culture

What even IS culture at an engineering-driven organization? I asked Aditi Chakravarty, an organizational effectiveness leader and the former chief culture officer at Lawrence Berkeley National Laboratory (who is also my wife). In the context of her work driving interdisciplinary leadership development at a 4,000+ person research institution, she said “Culture is the shared values, norms, and practices that shape and dictate behavior in social systems, including workplaces, departments, and teams.”

At startups, the path is rarely linear. After Synchron raised a $200m Series D last year, I asked Tom Oxley about the company’s move to San Diego. He charted the Stentrode’s migration across continents and coastlines, and spoke to the evolution of the CTO’s role from invention through iteration and vertical integration, in driving “hiring, values, culture, organizational development, supply chain, vendor relationships, contract negotiation.”

Speaking on the Juan Benet Podcast, Science Corp’s Max Hodak reflected on how judgment and culture are passed on in organizations: “You can’t really learn this through school. The best way I’ve seen is through apprenticeship. Humans are very mimetic…these cultures are oral traditions and practices. It’s kind of like a Jedi apprenticeship situation where you have to join the group. The only way to learn these things is by making big decisions with jeopardy and stakes attached… You go through a bunch of reps of that, and then you find out if you can learn it or not.”

Matt Angle posted this picture of a banner displaying Paradromics’ company values. An admirable lack of buzzwords!

Angle added by email: “We’re building the plane as we fly it. No one knows what a BCI company is supposed to look like. It’s definitely not a normal medical device company, but it’s not a semiconductor company or software company either. We’re building a new industry and culture is a critical part of it.”

What does “culture” mean to you? What does it mean in BCI?

Who is Hiring in BCI?

Which implanted brain-computer interface startups are hiring? We scanned through 16 firms with active roles on their career pages to explore the state of hiring today.

• Companies at the pre-clinical stage included Axo, Epia, Merge, and Subsense, though many roles at Science are focused on pre-clinical work as well.

• Companies with clinical programs, or those soon to enter human stage studies: Axoft, Blackrock, Coherence, Epia, INBRAIN, Motif, Neuralink, Neuropace, ONWARD, Paradromics, Precision,and Synchron. These 16 firms drove one-third of all applications on our job board, despite representing only 11% of the total companies represented since Q4 2025.

• 68% of full-time roles were technical roles. The other 32% included clinical, administrative, and business roles. Only two of the 16 companies (12%) posted salaries, and 5 firms (32%) had active internships posted. On average, companies were hiring in 2+ office locations, with 29 office locations across the US and 5 located globally.

Browse, apply, and add open roles for free today👉 neurotechjobs.io
Looking for a job in BCI? Watch for an exciting announcement this summer!

Neurosoft Bioelectronics’ Seed Round, New York Office, Hiring Plans, and Supercomputing Partnership

Neurosoft’s oversubscribed seed brings their total funding to $20m and follows an ecosystem partnership with Science Corp to advance their soft electrode platform. Founder and CEO Nicolas Vachicouras weighed in on the startup’s next chapter.

Congrats on the raise. Why is it the right time for Neurosoft to move to NY?

We are introducing a new era of cortex-wide systems neuroscience, leveraging our minimally invasive brain-computer interface platform built on stretchable electronics. The US is our primary market, so the move was natural as we prepare to launch our first product. NYC specifically made a lot of sense: it’s quickly becoming the center of gravity for neurotech in the U.S., and being closer to our collaborators removes friction. We are already in conversations with labs and clinicians who’ve been waiting on hardware like ours, and we’re excited to open that up to more partners across the USA.

What roles are you prioritizing hiring following your raise?

We are growing across research, engineering, and clinical teams. As we scale our clinical trials in Europe and the US, we are collecting an increasing volume of high-quality brain data, and building the neuroAI team to make sense of it. Most of our research hiring targets deep learning and time series specialists for whom neuroscience is a secondary but valued skillset. Our partnership with Science Corporation also creates new roles at the intersection of our electrode technology and their backend electronics.

The Swiss AI initiative recently awarded you a supercomputing grant. What are the business implications for Neurosoft, and supercomputing’s impact on the BCI field more generally?

Recording from the human brain is hard, and high-quality neural datasets are inherently complex: high sampling rates, many channels, across multiple brain regions simultaneously. Processing this type of high-dimensional time series data requires a level of compute that most academic and startup environments simply don’t have access to. The Swiss Alps supercomputer, currently ranked 8th in the world, changes that for us. In practical terms, model training that could take months on conventional infrastructure can be compressed into days or weeks, directly accelerating our path from clinical data collection to generalizable models of brain function.

From a business perspective, this is a meaningful step. At its core, neuroAI is about decoding recorded electrical brain activity into specific brain functions: translating raw neural signals into something clinically meaningful, like movement, speech, or cognition. Faster model iteration means shorter feedback loops between our clinical trials and our AI development, which translates into accelerated timelines for therapeutic applications. Access to compute is becoming a decisive factor in this space, similar to what we saw with large language models. This grant puts us in a strong position to move faster, and to build models that could one day generalize across patients and conditions.

Treating Paralysis and Digitizing Neural Data

The second episode of Juan Benet’s podcast features Dr. Ben Rapoport, chief scientific officer and co-founder of Precision Neuroscience. Rapoport describes himself as a “child of the field”—his father was a neurologist specializing in clinical electrophysiology—and in the interview, he traces the history of brain-computer interfaces, from the 1980s insight that movement is encoded by populations of neurons firing together, to the mid-2010s breakthrough in compute and machine learning that finally made neural decoding practical. He also describes the thinking behind Precision’s once-contrarian bet that electrodes resting on the brain’s surface could decode intended movement just as well as needles penetrating into it.

Rapoport compares today’s effort to map the brain’s electrical activity—across many people, over time, and across different functions—to the way genomics turned a readable biological code into something the tools of computer science could act on.

My biggest takeaway was how Rapoport sees the long arc of his work as a neurosurgeon, electrical engineer, and computer scientist, beginning with his father’s career and extending to his role as a father to two:

Make sure to subscribe to catch the next episode when it drops!

Visit PL Neuro’s growing hub of content, events, and more: https://plneuro.xyz

Disclaimer: This content is provided for informational purposes only. It reflects the views of the author(s) at the time of publication and should not be relied upon as financial, legal, medical, or investment advice. Views are subject to change. Featured projects are highlighted for informational purposes only. Inclusion does not constitute an endorsement, recommendation, or investment advice by the author or by PL Neuro. PL Neuro may hold a financial interest in some or all companies referenced. This material may contain forward-looking statements, including projections, plans, and expectations regarding future events or performance. Such statements are not guarantees, involve known and unknown risks and uncertainties, and are subject to change without notice.

Daycare germs are The Worst. Here’s your Dayquil-fueled notable neurotech updates from the last two weeks of May.

• Funding & Commercial: $70m+ in fresh capital for neurosurgical brain mapping, BCI, focused ultrasound, tDCS, and more. Medtronic’s $650m purchase of SPR was the most notable of several acquisitions across diagnostics, digital health, and eye tracking, but the MedTech giant faces an ongoing leadership transition in neuro. Other key leadership news worth noting too.

• The emergent Neurotech CRO stack: Oura’s two new partnerships with ResMed and Cambridge Cognition, BIOS Health’s spinout of Kordata, Clearpoint’s 10-year focused ultrasound deal, and an ophthalmology clinical research buyout are all the latest signals that neurotech’s best short-term business bets might be in biotech. Your thoughts welcome.

• Regulatory wins: Noninvasive neuromodulation gains more traction with Neurovalens’ de novo approval for PTSD and MagStim’s 510k for accelerated TMS. Meanwhile, Neuropace’s new AI clearance and ABILITY’s IMDD Approval show the ongoing evolution of clinical brain implants.

• Elsewhere in this edition: New Foundation models from Sophont and Alljoined. A new focused ultrasound industry group emerges. A global study of the mental health disease burden in Lancet. New research into speech-based cognitive assessment, exposome, sleep, consciousness, and clitoral nerve mapping. As always, fresh job postings, upcoming events and deadlines, & more!

In local news: I joined Omniscient’s Business of Neurotech podcast, wrote about a new spinout venture from BIOS, and published our second regulatory review last week. Check out a new partnership with Arkane Capital in the Community Board below and reach out as pertinent. Stay tuned for more neurotech analysis and commentary this month!

👋🏽 Hi, I’m Naveen. I believe brain health is human health. You are one of the 4,787 readers of my biweekly reports on emerging neurotech markets.
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• PL Neuro: Episode 3: Jacques Carolan — The Mission to Get Breakthrough Brain Treatments to Everyone - Watch Now

• Resonant Link Medical: If you’re looking for unprecedented performance, power to unlock new capabilities, and a faster, lower-risk path to market, meet Vivigo™ — Resonant Link Medical’s 20-Minute Universal Charger, now in its next generation.

• NANS: NANS Applauds Aetna for Revising Policy on Peripheral Electrical Nerve Stimulation for Pain Policy - Read More

• TTP: Exploring ultrasound-enabled devices? Discover the engineering lessons behind integrating ultrasound into complex product architectures. Find out more

• Datwyler: Join us in Mountain View, CA, June 10-11, 2026, at the TechBlick event, “The future of electronics RESHAPED.” Learn more and sign up!

• BrainMind: BioPhilia: How to Harness Nature for Wellbeing - Explore Infographic

  

Funding

• Omniscient Neurotechnology Closes $27.2M Series D to Expand Connectomics-Driven Clinical and BCI Applications (InsideBCI)

• Japanese Alzheimer’s Startup Sound Wave Raises About $17 Million (WSJ)

• Neurosoft Bioelectronics Closes $7.5M Oversubscribed Seed Round to Build Stretchable and Scalable Brain-Computer Interfaces (Morningstar)

• Kordata Launches to Advance Neurotech Powered Clinical Trials (Forbes)

• Psilera Closes Oversubscribed $8.8M Seed Funding Round to Accelerate Neuroplastogen PSIL-006 Into the Clinic (PR Newswire)

• ReVision closes oversubscribed €4m round (LinkedIn)

• Wearable Startup Sychedelic Raises $3.5 Mn in Seed Funding (Indian Retailer)

• UC San Diego Awarded $4.85M to Grow NEMAR into HPC Hub for Neuro-AI (UC San Diego)

• Neurotype Awarded NIH Phase II SBIR Support to Advance NeuromarkR™ (Neurotype)

Commercial

• Medtronic announces intent to acquire SPR Therapeutics, Inc., for $650 million, expanding care options for people living with chronic pain (Medtronic)

  • Medtronic Neuroscience head Brett Wall to depart, replacement named (Mass Device)

• CortiCare announced the acquisition of Integris Neuro LLC (Linkedin)

• Nexalin Acquires AI-Integrated Digital Health Platform Behind HALO™ Clarity and Nexalin NeuroCare™ Ahead of Planned FDA Pivotal Trial (Nexalin)

• Lexitas Pharma Services, a Leading Ophthalmology CRO, Announces the Acquisition of Erie Retina Research, CASExERIE and Element Erie (Business Wire)

• Strategic Analysis of the ResMed and Oura Partnership: Bridging Consumer Wearables and Clinical Sleep Medicine (Nelson Advisors)

• Launch of brain health study with Oura (Cambridge Cognition)

• ClearPoint Neuro Enters into 10-year Focused Ultrasound Development Partnership with Sungkyunkwan University, South Korea, Further Expanding Our Drug Delivery Ecosystem and Global Footprint (Yahoo)

• Brian Pepin announces departure from Rune Labs (LinkedIn)

• Alison Buick joins ki:elements as Therapeutic Area Lead, Alzheimer’s Disease (LinkedIn)

• TBC Taps Into Big Tech, Academic Networks to Secure New Strategic Advisors (PR Newswire)

• Naqi Logix Joins Lenovo Innovation Accelerator at BEYOND Expo at Macao (EIN Presswire)

Regulatory

• Neurovalens earns FDA nod for neuromod fo PTSD (Mass Device)

• MagVenture Receives FDA Clearance for Accelerated TMS Protocols, Expanding Flexibility for Clinics and Patients (MagVenture)

• Neuropace announces new FDA-Approved NeuroPace AI application for the RNS® System - designed to streamline iEEG review in PDMS (LinkedIn)

• ABILITY Neurotech Receives IMDD Approval to Start Clinical Trial for Chronic Implantation of Brain-Computer Interface in ALS Patients (Yahoo Finance)

• Nexalin Technology Secures key Neurostimulation Legislative Provision & Commends U.S. House-Passed Report Language Expanding Non-Invasive Deep Brain Neurostimulation Research at the Department of Veterans Affairs for Traumatic Brain Injury (Nexalin)

• OMB published 412 pages in the Federal Register that give political appointees the authority to terminate NIH grants, override peer review scores, and block publishing, attending conferences, or subscribing to journals with federal funds (LinkedIn)

📌Community Board

🆕Pin your news - Highlight key deals, events, roles, or announcements!

• Arkane Capital is looking for founders and scientists building novel applications of non-invasive neuromodulation for brain health that can replace drugs and invasive stimulation methods. If this describes you or someone in your network, please reply with pertinent materials.

• Before the June 5 deadline, Hear from Researchers Inside the SPARK NS Program (SparksNS | (Clinical Trials)

• New Global Clinical Society to Bring Focused Ultrasound Into Mainstream Medicine (Focused Ultrasound Foundation)

• Brain Tech Australia- early bird pricing available until 31 July by registering here: braintechaustralia.com.au

• Nucleate is building a fundraising guidebook to support early-stage life sciences founders as they navigate raising capital (Linkedin)

Industry

• Oral Health Map (LinkedIn)

• SetPoint Medical Announces First Patients Enrolled in Pilot Study Evaluating Neuroimmune Modulation for Multiple Sclerosis (Shepherd Center | Linkedin)

• Release of CortexMAE and Brainmarks, fMRI Foundation Models & Benchmarking Tools (Sophont)

• Decoding Emotion from EEG: Introducing NOVA (Alljoined)

• Neurotechnology Industry Trends 2026: BCI, AI, Neuromodulation, Wearable EEG and Neural Data Privacy (Brain Patch)

• Is AI Set to Supercharge Medical Devices? (WSJ)

• Mitacs helps Neron AI build brain assessment tools for medical and military use (Mitacs)

• BrainPatch launches Academic Program (BrainPatch)

• Terrific new report just out via the G7 France Presidency (Linkedin)

• Is the most impactful & innovative AI wearable in the world being built in Singapore? (Linkedin)

• Miruns is accepted into the Ignite programme at Cambridge Judge Business School (Linkedin)

• The Future of Brain Medicine with Owen Muir (NeurotechX)

• Blood pressure tech floods the market after FDA relaxes wearables oversight (Stat 10)

• NextSense: A novel, wearable, in-ear EEG technology to assess sleep and daytime sleepiness (Bioelectronic Medicine)

• Cerevia Neurosciences announces they were selected for the 2026 MedTech Innovator Accelerator Cohort through the American Heart Association Speciality Track (Linkedin)

• Four decades of Alzheimer’s disease discoveries, data, and research resources: The NIH Alzheimer’s Disease Research Center Program (Linkedin)

• The next generation of wheelchairs can navigate curbs and hold beverages (PittWire)

Neurotech.TV

• Jon Nelson and Amanda Geisinger at Asilomar for the Brain and Mind (Youtube)

• New Books in Neuroscience: Yosef Grodzinsky, “How Deeply Human Is Language?: Chomsky, the Brain, and the AI Fantasy” (Medlink Neurology)

• Inflammation, Limbic White Matter, and Symptoms After Repetitive Head Impacts in Retired Football Players (Spotify)

• Jacques Carolan - The Mission to Get Breakthrough Brain Treatments to Everyone (Youtube)

• Bernd Montag’s latest SHIFT Innovation Talk (Linkedin)

• “Lived Experience” in neurorehabilitation (Virginia Tech News)

• Groundbreaking treatment for depression with Dr. Owen Muir (Good Morning America)

Society

• EBC Introduces the Seal of Responsible Neurotechnology (European Brain Council)

• Linking the exposome to the brain–behaviour phenotype (Nature)

• Recommendations on post-trial responsibility in implantable neural device research: a multidisciplinary consensus study (Springer)

• China moves AI brain implants from trials towards real-world use (Nature)

• Attention Spans Aren’t Shrinking (Cognitive Wonderland)

• The Autism “Overdiagnosis” Debate Is Really About the Limits of the Medical Model (Linkedin)

• Beyond One-Size-Fits-All: A Neuroscientist’s Battle with Anxiety & Depression (ADAA)

• Your Brain Deserves the Same Care as the Rest of You (Linkedin)

• Scientists mapped all the nerves of the clitoris for the first time (Live Science)

Research

• Matthew Sacchet - What can the interface of sleep, consciousness, and advanced meditation teach us? (Linkedin)

• Speech-based digital cognitive assessment for clinical trials: Detecting cognitive impairment stages and AD biomarker relations across European cohorts (Alzheimer’s & Dementia)

• Premotor cortex uses a compositional neural geometry to plan words (BioRxiv)

• Machine Learning Doubles Depression Remission Rate (Neuroscience News)

• A deep-learning framework reveals whole-body perturbations at cell level (Nature)

• Updated trends in the global prevalence and burden of mental disorders, 1990-2023: a systematic analysis for the Global Burden of Disease Study 2023 (The Lancet)

• Printed devices turn neuromorphic (Nature)

• A clinically integrated, frameless human Neuropixels workflow (medRxiv)

• Sequential visual stimuli increase high frequency power in the visual cortex (Nature)

That’s a wrap! What did we miss? Let me know for next time.

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On the Reg is a new initiative to spotlight strategy, opinion, and insights from the neurotech field’s evolving regulatory landscape. It’s written for and by commercial leaders and experts from our audience of engaged readers.

Table of Contents - May 2026

• A 50 Year Outlook

• Regulatory Lessons from the Move to At-Home Use for Spinal Neurostimulation

• Short-Term & Long Term: Regulatory Pathways & New Tech Access

• Is CMS Killing Breakthrough MedTech? A View from the Other Side

• CDRH’s READI-Home Innovation Challenge Announced

• Regulatory Futures: How long does it take to bring a next-gen interface to market?

• Crucial Context for HHS Secretary Kennedy’s Anti-Antidepressant Push”

• FDA’s Guidance on Content of Human Factors Information in Medical Device Marketing Submissions

Thank you to our guest contributors and featured experts in this edition! Omari Bouknight from Resonant Link Medical & Nada Hanafi from MedTech Strategy Advisors, Susan Lubejko and Abby Copeland at Mittal Consulting, Blythe Karow at The Device Files, Jennifer Newberger and colleagues at the FDA Law Blog, Juan Benet from Protocol Labs & Max Hodak from Science Corp, Dr. Owen Muir from the Frontier Psychiatrists.

The Next 50 Years and the Next 50 Days

By Naveen Rao

Yesterday marked 50 years since the passage of the Medical Device Amendments of 1976, which created today’s “modern” risk-based framework for US medtech regulation. That makes today the first day of the next 50 years of FDA-regulated neurotech markets.

With SO many changes afoot and ahead at the FDA, it is a perfect time to call for bold thinking about the myriad opportunities to evolve regulation of neurotech devices meaningfully, systematically, and proactively. The last few weeks of federal activity offer policy mavens some ideas for how to manifest alternative futures for neurotech markets.

An April 18 Executive Order directed the FDA to issue priority vouchers for three companies developing psychedelic medicines for serious mental illness, plus an investigational clinical study by a fourth. The XO also commits $50m from ARPA-H to match state-level research efforts. This story is still evolving, but it’s turned a new chapter. Who in the neuromod industry will advance similar playbooks for bold policy action? Today’s momentum around fast-acting TMS, focused ultrasound, and even certain implanted neurostimulators are worth following closely.

On April 23, CMS & FDA announced the RAPID program, about a week after CMS proposed repealing NTAP. Is the new pathway (the third such attempt this decade) another narrow stopgap? Who will advance more systemic payment fixes to support competitive industry segments and prioritize fixes to accelerate innovation for patients while maintaining clinical rigor?

On April 28, The FDA announced a Real-Time clinical Trials Initiative for drugs. The agency has extended the comment period until July 29th. Will any device manufacturers seek inclusion in this new project, either for biomarker R&D, neuromonitoring, or long-term clinical studies for novel medical devices?

On May 12, the FDA Commissioner Marty Makary resigned, casting doubt over the modernization efforts he began. This triggered another wave of departures, including both veteran leaders at the agency and new appointments, such as the agency’s first ever AI Head after only months on the job. Advocacy groups have been trotting out names, but the agency’s challenges are compounding. Despite the well-documented challenges and outflux of neurotech regulatory experts to industry, CDRH has benefited greatly under Michelle Tarver’s steady leadership.

Over the next 50 years, what major policy reforms to medical device development will be remembered? Who is working on this in the next 50 days? The 50 days after that?

Short-Term & Long Term: Regulatory Pathways & New Tech Access

In Resonant Link Medical’s recent episode of Powering the Future Within, CEO Omari Bouknight sat down with Nada Hanafi, founder of MedTech Strategy Advisors, for a discussion about regulatory strategy, product development and long-term change at the FDA. Some highlights:

• On FDA BDD and initial submission strategy: “You shouldn’t tie your business strategy to your regulatory strategy. And vice versa. You should have a business strategy and a goal. Have your aspirational claims, whatever north star you’re shooting to and you should develop a regulatory strategy to support that….but don’t promise the world and not deliver on the minimum. It’s a stepwise approach: What we’re trying to tee up is a reasonable pathway to get you there because your aspirational claims may require extensive amounts of evidence, and you need to show some proof points of success. I’m not saying don’t think of the future…but if there is a narrower or more focused or more imminent patient population that can benefit, then let’s start there.”

• On Postmarket Surveillance: “It seems as though FDA has become more and more interested and willing and open to postmarket surveillance in a clinically driven way. Meaning that perhaps your follow-up period might be one or two years and you’re able to show a nice signal of safety and effectiveness and then FDA will say, ‘Well, this is a very innovative technology. We think that you’re starting to show benefit versus risk. We’ll let you on the market. we’ll prove the device and then we’re going to surveil you in a very clinically driven way going forward.’ So, it seems like that postmarket aspect will be more and more important and something that the agency is more and more interested in exploring.”

• On the next generation of FDA Leaders: “If we have more leadership that’s representative not just from a gender/sex perspective but from a race/ ethnicity, and I’m also a big believer on the age piece. Even seeing the political leadership in New York now I am so excited. So I think you need to have all all voices at the table in that sense…And having that ultimately, hopefully leads to access and better products.”

Is CMS Killing Breakthrough MedTech? A View from the Other Side

Blythe Karow, Founder & Principal, Karow Advisory Group, and Editor, The Device Files, published a a three-part interview series with Dr. Lee “No Video Games” Fleisher, the former Chief Medical Officer of CMS.

• Part One: Congressional action on “Benefit Category” could be a fulcrum for more systemic coverage reform across CMS. “So when CMS says it cannot cover something, sometimes what they mean is “we evaluated it and decided it isn’t reasonable and necessary,” which is a judgment call within their authority. And sometimes what they mean is “this isn’t a benefit category at all, we have no legal authority to pay for it regardless of how good it is.” Those are very different statements, but they are often voiced with the same shrug. So, according to Lee, the law was structurally flawed in part because it did not address benefit categories. It said, in effect, pay for things that in a lot of cases Congress had not authorized CMS to pay for.”

• Part Two - 2024 TCET program’s constraints limited the focus on PMA: An anonymous CMS source says that “TCET was scoped and implemented by CMS specifically for Pre-Market Approval (PMA) class devices by design.” Lee was at CMS during publication of the TCET pathway and knew that resources would be limited to five or so approvals a year, but the implementation of TCET was after Lee’s departure from CMS. Evidently the decision was made after his time that - because…the entire CMS coverage group has 35 to 37 people, in his estimate, possibly fewer now after departures earlier in the year. They are responsible for novel coverage decisions across a Medicare program that handles close to a trillion dollars in spending annually. As Director of CCSQ, Lee oversaw a $1.7 billion budget but couldn’t just shift $10 million from one program into the coverage group. The structure of CMS appropriations does not permit that kind of internal reallocation. Expanding the coverage group requires an act of Congress.”

• Part 3: CMS’ thinking behind NTAP’s demise, RAPID’s emergence, and more: “Lee’s explanation of what CMS is saying with this move came down to one word the CMS political leadership keeps using in his meetings: deinflationary. The argument from CMS is that too many devices that took the alternative pathway have not, in retrospect, demonstrated substantial clinical improvement over what was already available. CMS is no longer willing to take breakthrough designation as a proxy for the substantial clinical improvement criterion. Companies will have to show their work.”

Regulatory Lessons from the Move to At-Home Use for Spinal Neurostimulation

By: Susan Lubejko PhD and Abigail Copeland PhD, Regulatory Affairs Specialists at Mittal Consulting

The past two years have been prolific for non-invasive transcutaneous spinal stimulation. Onward Medical’s pioneering ARC EX System De Novo (DEN240014) was first cleared in 2024 for clinic use. This non-invasive technology is intended for improvement of hand sensation and strength in spinal cord injury patients when used in conjunction with functional tasks (i.e. daily living activities).

Since then, three 510(k) clearances have used this De Novo to enter the space:

1. Onward Medical’s follow-up ARC EX System submission (K251821, November 2025),

2. ANEUVO’s ExaStim Stimulation System (K252893, March 2026), and

3. Spinex’s xStep (K253638, April 2026).

The ARC EX and ExaStim 510(k) clearances stand out as they both move the technology from clinic only use (the original De Novo indication) to at-home use. ARC EX and ExaStim’s expanded use environment strategies are in alignment with a 2- step 510(k) approach that is expected for most novel devices to gain at-home use indications.

The first 510(k), or De Novo in Onward Medical’s case, pursued an in-clinic use indication, followed by a subsequent 510(k) for at-home use. This typical trajectory allows for manufacturers to collect data on novel devices in the controlled clinical environment and subsequently run additional studies to convince FDA that untrained users can safely use a device, follow the instructions, and effectively handle any glitches without major risk. ExaStim also followed the same pattern of using ONWARD Medical’s De Novo to prove the safety of in-clinic use and a 510(k) to gain at-home indications. Because the ARC EX 510(k) had not yet been cleared before ExaStim’s submission date, both manufacturers needed to independently provide data and rationale to support a use environment change from the same in-clinic De Novo.

While these clearances above follow a predictable 2-step pattern, what is interesting about them is the evidentiary burden required to support the 510(k)s. Review of the two 510(k) summaries reveals a relaxation in FDA’s usual expectations for use environment change by requiring relatively less additional validation data than has been necessary for past devices. Both devices likely benefited from ARC EX generating data on safety and user experience in clinical use. In addition to typically required testing for a first-time device, ExaStim was able to demonstrate safe at-home use through human factors/usability testing alone. More surprising is FDA’s clearance of ARC EX at-home use with no additional assessments performed, relying entirely on previously submitted De Novo data and the argument that the environment presents a negligible change, whereas usability testing is the norm for making this shift. This potentially signals that in the neuro space, FDA is becoming more comfortable with reducing evidentiary burden to segue to at-home use.

These case studies help inform future FDA interaction strategy about use environment shifts in the neuro space. Manufacturers making this transition should consider taking bolder steps to negotiate with reviewers on small, well-designed studies that can support this new indicated use without undue validation burden.

CDRH’s READI-Home Innovation Challenge Announced

By: Susan Lubejko PhD and Abigail Copeland PhD, Regulatory Affairs Specialists at Mittal Consulting

In April 2026, FDA announced the Reducing Readmissions through Device Innovation for the Home (READI-Home) Innovation challenge. The purpose of the READI-Home Challenge is to support manufacturers working on at-home devices that could appreciably decrease hospital readmissions. This is important because devices intended for home use face unique challenges due to the fundamental differences between the home and clinic. Device usability by patients and caregivers, instructions for use, and environmental risks must be considered during device design, validation, and premarket submission.

To understand where READI-Home fits into FDA’s overall strategy for at-home devices, let’s look at CDRH’s historical efforts in this space. Driven by public request for guidance on demonstrating safety and effectiveness of home-use devices, in 2024 CDRH began to address this concern by establishing the Home as a Healthcare Hub Initiative. Home as a Healthcare Hub is composed of an online Idea Lab which is currently exclusively focused on patients with diabetes. It is an online resource designed to show manufacturers the real-world challenges patients face using fictional personas and virtual reality software that simulates their at-home lives.

While Home as a Healthcare Hub provides awareness and conceptualization support, it does not provide incentives or direct FDA regulatory support for premarket acceleration of these devices. Therefore, the READI-Home program was created to fill this gap in the original program. In this new READI-Home program, FDA is recruiting a total of nine (9) devices from distinct manufacturers that meet the following criteria: 1) should address an unmet health care need in the home, 2) be intended for use by the patient or caregiver at home, and 3) demonstrate feasibility to reduce hospital readmissions.

Selected participants will have the opportunity to engage in Sprint discussions (accelerated FDA discussions which are already a standard option for Breakthrough Devices) to refine device design and testing and can also live-demo their technology in-person at FDA research facilities. Because this is a new program beginning its first interaction phase in December, specific details will likely be forthcoming; however, if FDA follows the same format for Breakthrough sprint discussions, these may consist of single-topic negotiations with FDA reviewers on a predetermined timeline. This would vastly decrease the time to FDA feedback compared to standard premarket avenues and, ideally, the time to market for selected devices.

Until the interaction phase of READI-Home begins, questions remain regarding the potential success of the increased FDA interaction, but the possible upside is high for novel device manufacturers looking to accelerate time through the premarket phase. If you are a device manufacturer developing premarket at-home devices with promise to reduce hospital readmission, make sure to apply to READI-Home challenge using the Q-Submission process by September 30 to be considered.

Regulatory Futures: How long does it take to bring a next-gen interface to market?

On Juan Benet’s inaugural podcast episode, Max Hodak anticipated the path to bring a biohybrid BCI into the commercial market through the FDA. He has also spoken about leveraging AI internally to accelerate regulatory requirements.

As the next wave of high-risk, high conviction bets in brain health emerges, how could regulatory science change with the times, not for cutting corners or skipping steps, but for accelerating clinical discovery and time to impact?Listen to the whole episode to learn more about Science’s business model and regulatory strategies.

Crucial Context for HHS Secretary Kennedy’s Anti-Antidepressant Push

This is is excerpted from Dr. Owen Muir’s tremendous substack, The Frontier Psychiatrists, where this originally appeared in response to the HHS Secretary’s recent “push to help Americans quit antidepressants.”

• “What was missing, for me, from both Kennedy’s plan—emphasizing only nutrition, exercise, and other demonstrably beneficial lifestyle interventions—was any mention of other effective biological treatments that don’t have the same risk profile…. But nobody mentioned what the other interventions might be!

• It’s Brain Stimulation. Brain stimulation exists! In various forms, it is FDA-cleared and FDA-approved already. In-home and in clinic! It involves treatments like ProlivRx, the Flow Device, transcranial magnetic stimulation, and deep brain stimulation, covered ad infinitum in this very newsletter. It also includes accelerated forms of treatment like SWIFT, SAINT, and investigational One-D. It even involves self-neuromodulation using EEG-fMRI biomarkers, like Prism.

• There are even entire companies, such as Salma Health, my company, Radial, Beckley Clinical, and Mindful Health Solutions, that provide such treatments. If only there were an organization that could help set priorities for these non-pharmaceutical treatments for depression? You know something like a department, for health, or humans, or services, that included a massive national mechanism to determine how things might be paid for under either Medicare or Medicaid?

• Oh, wait, CMS exists too! They can make a call to action! In fact, they’re just calling themselves with a call to action. They can just “to action!”

  What “action” you ask? Remove prior authorization requirements for transcranial magnetic stimulation and other breakthrough neuromodulation treatments. Cover these things under Medicare, don’t require prior medication trials, because that means more antidepressant prescribing, which the evidence shows is dangerous for some people.

  Regulate health insurance payors similarly. When payors have policies that require patients to go back to drugs to get brain stimulation… maybe HHS could look at the above evidence. They could say: “That’s not something health insurance companies in America are allowed to do anymore.”

• There are several steps CMS could take tomorrow. Unfortunately, they weren’t mentioned in the article or in Robert Kennedy’s announcement, and this seems like a miss to me. I humbly submit that if HHS covers brain stimulation treatment more broadly than it does medications, the problem will resolve more quickly. Now, where are the steps off this soapbox so I don’t trip and fall on my face?”

Content of Human Factors Information in Medical Device Marketing Submissions

As summarized by RAPS, “The US Food and Drug Administration (FDA) has finalized a revised draft guidance from 2022 on what human factors (HF) information sponsors should include in premarket submissions for medical devices. On 28 May, FDA published the final guidance, which includes additional risk-based factors that sponsors should consider when determining the human factors submission category, new examples in the appendices, and clarification about the scope of the guidance. While the guidance applies to marketing submissions for medical devices, including 510(k) premarket notifications, De Novo requests, and premarket approval (PMA) submissions, the final guidance also addresses combination products.”

Check out the upcoming Town Hall on Content of Human Factors Information in Medical Device Marketing Submissions, Final Guidance

• Date: July 22, 2026

• Time: 1:00 – 2:00 p.m. ET

That’s a wrap!

Thanks again to our contributors for helping launch this inaugural edition.

Hit reply and let me know: What regulatory headlines are most important for founders, commercial leaders and investors to understand, and why?

• Tell me about specific company approvals or clearances, or related trends analysis of markets, modalities, sectors you want to see covered.

• Ditto for program level analysis and interpretation across FDA, CMS, other agencies.

• Yes, I am interested in covering more global market developments from Europe, Asia, and all other markets. No, I cannot do this on my own so please get in touch if you want to collaborate!

Thanks for reading and sharing with your colleagues.

I’m still fizzing from last week’s event! Thanks to our sponsors, attendees, supporters. Full recap coming soon, along with the next meetup….stay tuned! Here’s your roundup of major neurotech industry headlines from the first half of May:

• $100m in fresh capital, not including Mobia’s $150m IPO and Neuralink’s unknown OIA funding, was invested in mental health or implanted bladder neuromodulation. Tim Ferris’s vocal support into Ampa’s round is worth more than his money. New grant awards in NeuroAI, organoids, and sleep, as well as new government and philanthropic funding opportunities.

• New products and partnerships announced from Prophetic, Greymatter, Cadwell, Neurocatch, along with newly published studies from SetPoint, Cortec, MyndSpan, and executive appointments at startups across a range of indications and modalities.

• Galvani Bioelectronics’ shutdown adds a high profile headstone to the commercial neurotech graveyard. Makary’s ouster at the FDA leaves a cloud over the agency, again. The “US-China” BCI dynamic continues gaining media coverage. What do you make of these updates?

• When “research” and “society” are venning, it’s a good sign: New studies and commentary on sleep’s impact on middle-age & late life aging clocks, psilocybin, ADHD. Plus: Bioelectronic contact lens, speech studies, and more.

Other updates from Neurotech Futures before diving in:

• We sponsored our first webinar in partnership with Neurofounders, covering neuron-based biocomputing’s early commercial phase. Scroll down to catch the full conversation with Ewelina Kurtys of FinalSpark and Brett Kagan from Cortical Labs in Neurotech.TV below👇

• The latest edition of Signals covered last month’s news from Motif, Mint, Epia, Axoft, Neurable, Noctrix, Bioness and Neuraxis. As a reminder, you can unlock free access by sharing this with your network!

• Do you have a regulatory perspective, analysis, or opinion to share with our global audience of neurotech commercial leaders? On the Reg is our latest series - check it out and let me know if you would like to contribute.

👋🏽 Hi, I’m Naveen. I believe brain health is human health. You are one of the 4,713 readers of my biweekly reports on emerging neurotech markets.
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• PL Neuro: Leadership, Infrastructure, and Investability: Neurotech’s Rising Tide - Read More

• Resonant Link Medical: MedTech funding is moving, but still playing catch-up, says Campbell Murray, managing partner of Double Point and architect of Synchron’s $200m series D. Hear why on the latest episode of Powering the Future Within.

• NANS: ​NANS Publishes New Curriculum for Deep Brain Stimulation (DBS) Training - Read more

• TTP: From early concept to clinical readiness, neurotechnology development is full of critical decisions. TTP helps you get to first-in-human faster by resolving complexity early. Find out more

• Datwyler: Wearable devices must provide value for the user while meeting high comfort expectations. SoftPulse® dry electrodes achieve best performance while maximizing comfort thanks to optimized formulation and scalable customized production process. Learn more or contact us directly.

• BrainMind: Stay tuned for output from Asilomar! Follow BrainMind’s LinkedIn page to stay on top of all updates.

Funding

• Mobia Medical Announces $150m Initial Public Offering (Mobia)

• Oman Investment Authority backs Elon Musk’s Neuralink in push into neurotechnology and BCI systems (Fast Company Middle East)

• BlueWind Medical Secures $47.8 Million Financing to Accelerate Commercialization of Revi® System (PR Newswire)

• SonoMind announces a €20M Series A to accelerate the development of our new non-invasive approach to treating treatment-resistant depression (Linkedin)

• Ampa Accelerates Rollout of Portable Neuromodulation Platform for Depression with Oversubscribed Financing (PR Newswire)

  • This was ~a $17m round. What questions do you have about Ampa’s rise and evolving trajectory for fast-acting mental health?

• EBT Medical and NinaMED Announce $13.75M Financing to Advance Licensed NiNA System® for Overactive Bladder (PR Newswire)

• Nexstim Plc Announces EUR 5 Million Investment from Eiffel and from Brainlab and Conversion of Options by Certain Option Holders (Nexstim)

• Neurosoft Bioelectronics wins grant from Swiss AI Initiative to access Alps, the supercomputer operated by CSCS supercomputing centre (Linkedin)

• Nuream wins NC IDEA grant for sleep AI ( NCIDEA)

• Announcing the Winners of the NIH Replication Prize: Shaping the Future of Rigorous Science (NIH)

  • Alysson Muotri from UC San Diego will recieve support for his idea, “Making human brain organoids more reproducible and consistent.” Check out PsyMed’s latest podcast to learn more about Muotri’s work

• ARPA-H SBIR/STTR Draft Solicitation has officially launched (Linkedin)

• The Wellcome Prize for Mental Health Science with Nature launches $1m prize for new interventions for anxiety, depression and psychosis (Nature)

Commercial

• Galvani Bioelectronics Prepares for Orderly Shutdown (Linkedin | Neurotech Reports)

• Prophetic announces launch of two products to “enhance how humans dream:” Dual ($449, Q4 2026) and Phase ($1299, Q3 2027) (Prophetic X)

• GrayMatters Health Launches Prism™ Imagine, “a generative AI-powered tool for interventional psychiatric clinics to enhance patient engagement.” (PR Newswire)

• NeuroCatch Inc. Announces Strategic Partnership with The Geneva Foundation to Advance Cognitive Health Research for Military Personnel (The Geneva Foundation)

• Cadwell Launches Cadwell Guardian IONM System in the United States (PR Newswire)

• MMI’s Symani Surgical System Treats First Alzheimer’s Patient in Groundbreaking REMIND Study (MMI)

  • Who knows about microrobot startups? Who’s out there besides MMI and Robeauté?

• Neurotechnology leader Nicholas Opie joins Control Bionics board (Biotech Dispatch)

• NeuWire Medical Appoints Ramin Mousavi as Executive Chairman Following Stroke Journal Publication (BusinessWire)

• Spark Biomedical Appoints Anja Krammer as Chief Executive Officer to Accelerate Clinical and Commercial Growth (Business Insider)

• Professor Jianfeng Feng has joined Gestala’s Scientific Advisory Board (Linkedin)

• Stimvia Expands Scientific Advisory Board and Commercial Leadership to Advance Global Market Scale-Up of URIS® Neuromodulation Therapy” (PR Newswire)

• Wyss Geneva is thrilled to welcome Wolf-Julian Neumann to the Leadership Team as Head of AI Innovation and Therapeutic Neurotechnology (Linkedin)

• Two Medtech Industry Leaders Selected to Serve on NIH HEAL Initiative® Multi-Disciplinary Working Group (Globe Newswire)

• Inspire Medical slashes 2026 guidance amid reimbursement uncertainty (Mass Device)

  ---

Regulatory

• Epineuron Receives FDA 510(k) Clearance for Evala® Nerve Stimulator (BusinessWire)

• PlatoCare: first wireless tDCS EU MDR approved depression treatment (Linkedin)

• Makary’s time atop FDA over, Diamantas named acting commissioner (Politico)

• American Brain Coalition Launches New Community Engagement Platform to Strengthen Collaboration Across Brain Health Field (ABC)

📌Community Board

🆕Pin your news - Highlight key deals, events, roles, or announcements!

• Corey Keller on the PhD wall in Neurotech (Linkedin)

• The Brain-Computer Interface Priority Setting Partnership: Shaping the Future of Brain-Computer Interface Research - Survey

• Dana Foundation accepting LOI’s for pilot projects in Neuroscience and Society (Linkedin)

Industry

• Towards Solving Brain Aging: The most important problem in medicine, and the case for acting now (Amaranth Foundation)

• System changes to empower primary care in Alzheimer’s disease detection and care (Alz Journal)

• Geminii to Present New Lung Cancer Data on Its Bioelectronic Therapy at AACR 2026 (PR Newswire)

• Why Brain Implants Are More Than a Sci-Fi Fantasy (Bloomberg)

• Raymond James deepens Baycrest Foundation relationship to help Canadians protect brain health, wealth and family legacy (Yahoo Finance)

• Mind Over Matter: How Neuroscience is Redesigning the World Around Us (Milken Institute)

• DiMe’s Navigator: Why Teams Still Stall On Digital Endpoints (Clinical Tech Leader)

• Brain&AI team announces a new release with NeuralBench (Linkedin)

• Release of BrainFlow adds support for Muse Athena devices (Linkedin)

• 100,000 Clients Later, Cereset Says It Can Reset Your Brain Without Medication (Morningstar)

• Sharma Lab Deploys Open-LIFU for Multidisciplinary Neurological Research at NC Sate, UNC (ITN)

• SetPoint Medical Announces Publication of Cost-Effectiveness Study Confirming Neuroimmune Modulation Can Reduce Total Cost of Care and Improve Quality of Life for Patients with Rheumatoid Arthritis (SetPoint Medical)

• Openwater announces new software upgrade to Open-Motion (Linkedin | Openwater)

• MYndspan Scientists Publish Study Showing MEG Can Classify Parkinson’s Disease from a Short, Non-Invasive Brain Scan (Fitt Insider)

• Christian Angermayer’s Enhanced Games files to go public via SPAC (PR Newswire)

• Cortec: Neuromodulation via Subdural Cortical Stimulation Improves Hand Function in Chronic Stroke using a first-in-human fully-implantable recording and stimulation system - Abstract (INS 2026)

• The Meteoric Rise—And Problematic Future—Of Wearable Sleep Tech (Forbes)

• Renaissance Philanthropy Annual Report (Renaissance Philanthropy)

• A big question for brain-computer interface tech: How big is the market? (Pitchbook)

  • I had a back and forth with a Fund-of-Fund investor about this. I pooh-pooh’d it, saying “it felt stale, like it’s from 5 years ago”. He said “Having a large well respected research firm like Pitchbook is a good signal to legitimize BCIs outside of people that are familiar with BCIs.” What do you think?

• Mental Health Research Funding: A Decade of Growth, Inequity, and What Comes Next (IAMHRF)

Neurotech.TV

• Amy Kruse Talks Venture Investing in Neurotech (Business of Neurotech)

• Announcing the Inaugural Neuroarts Global Summit (Intl Mind + Arts Lab)

• Sana Health Advances Toward Global Scale in Pain and PTSD Care (Startup Health)

• Ben Rapoport - Treating Paralysis and Digitizing Neural Data (Youtube)

• The Doctor Building Real-Life Cyborgs (Youtube)

• The Biology of Brain-Machine Interface Failure (Youtube)

• Precision Neuroscience CEO on Medtronic Partnership, What’s Next (Bloomberg)

• What does it take to engineer a smaller, lighter, and more ergonomic PRIMA? Watch Episode 1: Our team tackles the next generation PRIMA Glasses. (Science Corp)

• Surviving the workplace with Min-Hsuan Tu (Buffalo)

• All Videos from the EU Brain Economy Summit (LinkedIn)

Society

• Here’s What Psychiatrists Mean When They Say You Have A.D.H.D. (NYTimes)

• The Race for Human Intelligence (Linkedin)

• How can healthcare innovation ease the impact of workforce shortages? (Linkedin)

• Neurotechnology: How Geneva is trying to hold its own against Silicon Valley (Heidi News)

• China’s recent developments and what they mean for the U.S. (Paradromics)

• Going home, young sci-tech returnees plug into China’s innovation drive (English News)

• Convicted former Harvard scientist rebuilds brain computer lab in China (Yahoo News)

• Recap: The Rhythmic Forum (Carolina Center for Neurostimulation)

• Neuroethical evaluation of neuromodulation for stuttering: Implications for agency, identity, consent, and social meaning (National Library of Medicine)

• How Does the Brain Control Itself? (BrainFacts)

• Silicon Valley Wants to Put a Chip in Your Brain (Politico)

• Why expertise won’t protect you from AI’s influence (The Transmitter)

• AI and the danger of cognitive surrender (The Economist)

Research

• Human brain changes after first psilocybin use (Nature)

• Psilocybin and CBT for Cocaine Use Disorder: A Conversation with Sara Lappan, PhD (BrainFutures)

• An ultrasound-scanning in vivo light source (Nature)

• Finally, ADHD Has A published accelerated TMS Trial (The Frontier Psychiatrists)

• Comparison of neuropsychological side effects between contemporary radiofrequency ablative neurosurgery for psychiatric disorders and conventional neurosurgical procedures: systematic review and meta-analysis (BMJ Journals)

• Speech as an objective measure of psychomotor dysfunction in major depressive disorder: validation from non-speech motor measures (Science Direct)

• Contact lens bioelectronic platform for non-invasive depression treatment with machine-learning-based evaluation (Cell Reports)

• Many Pipelines, One Dataset: Analytic Flexibility And Its Impact in EEG Research (OSF)

• Pulsed focused ultrasound for seizure suppression: Mechanisms, models, and clinical translation (Neurotherapeutics)

• Sleep chart of biological ageing clocks in middle and late life (Nature)

  • Let’s add this to SleepFM as a groundbreaking sleep study published this year.

    

That’s a wrap! What did we miss? Let me know for next time.
Did you know you can unlock free membership by referring your friends and colleagues to Neurotech Futures?

Happy Friday! Welcome back to Signals, a members-only newsletter analyzing key commercial developments across the neurotech industry each month.

This edition covers top developments from April 2026, which produced a flurry of commercial milestones across implanted BCI and non-invasive neuromodulation that reveal how markets are evolving:

• Motif and MintNeuro Partner on BCI Chip Layer

• Epia Neuro Emerges as Stroke BCI Moves Toward Recovery

• Neurable Turns Consumer EEG Into an OEM Layer

• Axoft’s $55m Series A brings BCI closer to Biotech

• Will Noctrix’ Acquisition Drive New Interest in Wearable Neuromod?

• Bioness Medical Acquires the Portable Neuromodulation Stimulator (PoNS System

• NeurAxis Expands Payer Coverage with Four New Medical Policies

Let’s dive in.

(And don’t forget, if you are allergic to paying for neurotech analysis, you can still unlock free access by sharing this newsletter with your network!)

Read more

Representations is a new limited series exploring neurotech’s evolving business frontier. This is produced in partnership with PL Neuro, a project by Protocol Labs. PL Neuro accelerates neurotechnology and neuro AI through field building, strategic investment, and scientific research. Their worldview is deeply technical at every level, yet wholly focused on enabling futures of human flourishing and empowerment. Over the coming months we’ll explore key topics, trends, and themes, featuring experts from PL Neuro’s ecosystem and market insights curated from Neurotech Futures’ platform.

Welcome back to Representations. Last time we charted BCI in the AI Era, wherein rapid advances to data flywheels and business models are unlocking upmarket applications and platform opportunities for neural interface startups.

April brought us new companies, partnerships, fundraises, authorizations, leadership moves and more across BCI. We’re sharing a new market memo that tracks and tallies commercial activity across the sector, year to date.

This edition also highlights topics in infrastructure and leadership. These critical forces are shaping the generational business opportunity to usher in a safe and sustainable cybernetic era in the coming decades.

Clinical ARR: Smoothing The Path to $100B

Protocol Labs published the first of their Brain–Computer Interface Roadmap Series this month. It’s for investors, policy makers, and strategists interested in an ambitious but clear-eyed outlook for how today’s BCI leaders could - and should - achieve collective market success for restorative neurotechnologies.

• First, traditional FDA pathways to regulatory approval are increasingly misaligned with “living devices” that use adaptive AI algorithms designed to improve post-implantation.

• Second, the regulation-reimbursement disconnect remains a quantified structural risk that renders novel treatments inaccessible to most patients, and encourages iteration over innovation.

• Third, clinical adoption — established neurotech therapies like DBS and VNS achieve only 3–9% penetration of their addressable patient populations, due to physician workflow barriers and legacy risks of traditional surgical methods and devices.

More than simply navigating the Valley of Death, the authors call for a multifaceted and concerted infrastructure building plan, with the goal of building a sustainable business for restorative BCI recipients and their supporting clinical and product teams on the device side. We’ve seen the alternative and it isn’t pretty.

The 5-year action plan has three pillars: (1) compress the FDA-CMS reimbursement gap to under 12 months by leveraging the TCET pathway and pursuing Congressional action; (2) establish shared CPT code frameworks across device classes, rather than leaving each company to negotiate codes independently; (3) create a mechanism to provide patient support if a manufacturer fails, a precondition for patient trust that no single company can credibly provide on its own.

Since this paper’s publication, the CMS & FDA’s new RAPID program and other agency developments suggest the proposed strategy could prove effective. I found the policy and industry strategies it sets forth provocative, like embedding “Neurotech Fellows” at CMS and funding an “Orphan Implant Backstop.” For aspiring (or lapsed) neurotech policy wonks, print this out and bust out the highlighter.

For investors looking for emerging markets: With systemic changes afoot at the FDA, CMS, and beyond, it is a good time to pay closer attention: BCI’s value potential is no longer speculative, aiming far beyond today’s $8.8 billion neurotech market.

Next-gen, AI-adaptive systems could drive $100B+ in annual revenue within a decade, following an adoption curve similar to how cochlear implants and DBS went from experimental to established standards of care.

Finally, the authors and advisors to this paper comprise a who’s who of innovation architects at ARIA, Astera Institute, Renaissance Philanthropy, leading venture funds, medical centers, and startups. So it’s worth skipping your next slopscroll to spin through this instead.

BCI Market Memo: Capital & Commercial Activity In 2026

From January through April of 2026 we compiled commercial announcements across implanted BCI into this market memo. It offers a non-exhaustive, representative point-in-time analysis of the major drivers behind the field’s rise: funding growth, commercial ecosystem development, regulatory advances, and widening competition.

• $653m in new capital, led by raises from Merge Labs and Science Corp, defined a historic surge compared to this same period in previous years. Yes, big rounds are still in, but to benchmark against last year: there are two months left to go in H12026 and year-to-date funding is already at 45% of last year’s $1.46b. At this pace, 2026 BCI funding will hit $2b.

• Boston Scientific’s $14b acquisition of Penumbra, while not a “BCI” play, is a bet on greater neural access by a DBS company making regular neurotech acquisitions. This visual omits Mint Neuro’s May 1st deal with Motif, which adds evidence of a burgeoning commercial ecosystem following Precision-Medtronic and Science-Neurosoft deals inked in Q1.

• Over 18 clinical partners launched collaborations with BCI startups for various human-stage research efforts, led by Paradromics, Motif, Cortec, and others. This year will see a slew of first-in-human implants by companies building applications across stroke, vision, limb, prosthetics, TBI, psychiatry, and speech. Synchron’s pivotal trial will also kick off this year following their $200m series D. Meanwhile, Neuracle’s commercial clearance from China’s NMPA represents a global milestone on several levels.

• Chinese BCI investment crossed $100m in Stairmed, Gestala, and Axoft. The trend to monitor is the breadth of investors backing China’s BCI revolution, from regional and globally oriented venture capital firms, to family offices, state-run syndicates, and multinational corporate interests across robotics, pharma, e-commerce, manufacturing, and AI. There is much more happening in China. While beyond the scope of this memo, BCI geopolitics are of growing importance and will continue to inform global strategy across the field.

There are the usual caveats on company inclusion, categorization, and representation in this memo. Please note that any mistakes, oversights or editorial decisions were mine alone. If you have feedback, methodology questions, ideas, or just want to know more, hit reply or send me a note.

NeuroMaxxing: Juan Benet and Max Hodak discuss the next decade of the human brain

If you, like me, are intrigued about what’s going on inside the mind of Science Corp’s founder and CEO Max Hodak (one of Time’s 100 most influential people) PL Neuro’s inaugural podcast Restoring Sight, Growing Neurons on Silicon, and Expanding Human Intelligence, is just for you.

Juan adeptly weaves history and culture into questions about neurobiology and deeptech, beginning with a history of pre-clinical BCI work from the 1960’s to the development of the Utah Array at the turn of the century, through the last decade of advances in miniaturization, materials, and modernization, powered by what Hodak calls the “Smartphone Dividend.”

There is too much to summarize from the two-hour episode: Blind 81-year-olds reading newspapers and crosswords in the PRIMA trial; navigating biological constraints in neural engineering while adopting systemic and operational innovations; Max’s origin story and purview on hiring, culture, leadership; the current AI moment, and more.

The heart of this episode renews BCI’s grand vision, speculates with Juan on known and unknown sensory and cognitive enhancements, and offers a deep dive into biohybrid arrays, from neuronal biochemistry, de novo optogenetic proteins, risks, timelines, applications, and more. Like Science Corp’s secret master plan:

Make sure to subscribe to catch the next episode when it drops!

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Disclaimer: This content is provided for informational purposes only. It reflects the views of the author(s) at the time of publication and should not be relied upon as financial, legal, medical, or investment advice. Views are subject to change. Featured projects are highlighted for informational purposes only. Inclusion does not constitute an endorsement, recommendation, or investment advice by the author or by PL Neuro. PL Neuro may hold a financial interest in some or all companies referenced. This material may contain forward-looking statements, including projections, plans, and expectations regarding future events or performance. Such statements are not guarantees, involve known and unknown risks and uncertainties, and are subject to change without notice.

Here’s another BIG edition filled with commercial announcements across markets, modalities, and our own upcoming programming at Neurotech Futures. Some highlights to guide your weekend reading:

• Business Season: Congratulations to Noctrix, whose acquisition by ResMed was announced this morning. Plus: Neuraxis’s reimbursement news and ANEUVO’s FDA clearance. New partnerships between Mint Neuro & Motif, Piramidal & IntraNerve, and new platform plays from Neurable, Neuvotion, Zeto, and AHG.

• Funding: $200m in new capital deployed to Axoft, Cala, Nervonik, Sinaptica, and others. New grants from ARPA-H and other funders awarded to neurotech startups, research labs, clinics. New ideas from ARIA. Check out a few open funding announcements with upcoming deadlines, too.

• Clinical: Motif’s IDE gets the green light. Setpoint’s launches new MS trial. Precision and UChicago partner up. Cortec’s third-in-human and FDA Tap acceptance. INBRAIN’s first-in-human data.

• Regulatory: Huge neurotech business implications from Washington, with a new RAPID reimbursement pathway and Real-Time Clinical Trials pilot announced this week. We’re covering all things DC in more depth through our new newsletter, On the Reg. Hit reply - I want to hear from you about these new programs.

AND MORE: Research papers, social commentary, investor outlooks, fresh jobs. Look for exciting bits about fascia, octopus, mitochondria, patient perceptions in FUS, another octopus, upcoming events, and much more.

🗓️ Save the Date! Two New Events in May

1) May 12: The Rise of Biocomputing: Using Neurons as new Computing Systems

On May 12th we’re sponsoring our first webinar with Neurofounders! Join us live to ask questions to leaders from Cortical Labs and FinalSpark. If you cannot make it, send us your questions. A recording and summary article will be sent out afterwards.

These are just two companies pursuing commercial applications, with other leaders and more to emerge. Following a private tour of The Biological Computing Company’s lab, I am deeply intrigued by the upside for neural organoids & biological computing. I want to know your top questions and meet your expert colleagues.

2) May 13: Dreams of Our Future: A Neurotech Odyssey

Join me in San Francisco May 13th at 7pm for a networking reception featuring some of my favorite neurotech visionaries! I’ll share the stage with some special founders building across the gamut of neurotechnology:

• ​Blake Gurfein - CEO & founder, Fareon

• ​Elise Jenkins - CTO & cofounder, Coherence Neuro

• ​Corten Singer - President & cofounder, Augmental

• ​Keith Murphy - CTO & cofounder, Attune Neurosciences

• ​Nathalie Gouailhardou, CEO & founder, Neurode

• ​Avery Krieger, CEO & cofounder, Constellation

• ​Michel Maharbiz, CEO & cofounder, Epia Neuro

• Omari Bouknight, CEO, Resonant Link Medical

The venue only holds 250 guests so register now and plan to arrive on time! There will also be an open bar + company demos + a private investor lounge.

I’m co-hosting this with Human+ Tech Week, whose Future of Healthspan event takes place before (and a few blocks away from) this. If you want to connect 1:1, the HTW forum is a great place to do it, so register with my discount code and reach out to grab a time there.

👋🏽 Hi, I’m Naveen. I believe brain health is human health. You are one of the 4,280 readers of my biweekly reports on emerging neurotech markets.
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• PL Neuro: Eon’s demonstrated what it believes is the world's first whole-brain emulation producing multiple behaviors: uploading a fruit fly brain (140,000 neurons, 50M connections) into a physics-simulated digital body. The announcement went viral on X with millions of impressions and sparked genuine scientific debate.

• Resonant Link Medical: “Old Ideas, New Innovations”, with Neuroloop, Cadence Neuroscience, and More - Watch the Webinar and Connect with Omari to learn more.

• NANS: NANS Urges UnitedHealthcare to Revisit Stroke Therapy Coverage - Read the Letter

• TTP: What’s it like to work with TTP? A perspective from a Start-up CEO and President, Paul Goode, PhD.

• Datwyler: Join us in Mountain View, CA, June 10-11, 2026, at the TechBlick event, “The future of electronics RESHAPED.” Learn more and connect!

• BADASS Labs: Your Lab, Your IP: Unlocking the Bay Area with Zero-Equity Shared Lab Space - Read More

  • Pssst - I work out of BADASS Labs Alameda office! Let me know if you want to arrange a visit or learn about their wet lab space.

Funding

• Axoft Secures $55M Series A to Advance Clinical Trials Globally for its Bio-Inspired, Implantable Brain-Computer Interface (Business Wire)

  • US Brain Implant Company Tests in China in Apparent First (Bloomberg)

• Trinity Capital Inc. Provides $50 Million in Growth Capital to Cala Health to Support Commercial Expansion of Wearable Tremor Therapy (PR Newswire)

• Nervonik Announces $52.5 Million Series B Financing to Advance Peripheral Nerve Stimulation Therapy (MorningStar)

• Era raises $11M to build a software platform for AI gadgets (TechCrunch)

  • If you find this interesting please reply and tell me why.

• Sinaptica closed an oversubscribed $9 million round (LSI)

• Khosla Ventures backs Sabi’s EEG Beanie (Wired)

  • Sabi’s cap will have anywhere from 70,000 to 100,000 miniature sensors. Chhabra says the company has so far amassed 100,000 hours worth of brain data from 100 volunteers.

  • More on Sabi from Dominic here. I honestly don’t understand this one. If you know more about Khosla’s interests here my inbox is open.

• Cerca Magnetics Secures £3.8m/$5.2m in Series A Funding to Scale Quantum Brain Scanner (Quantum Insider)

• Neurava Awarded $4 Million NIH Blueprint Optimizer Award to Develop SUDEP Risk Stratification Algorithm (PR Newswire)

• Gabify, an Indian startup solving neurodevelopmental challenges in children, raises $175,000 in funding (Indian Startup Network)

• ARPA-H announces first research teams in $139 million initiative to transform behavioral health (ARPA-H)

• 2026 Eli Lilly and Company Grand Challenge Grant Application (Nucleate)

• SOMA Foundation Grant Program (SOMA Foundation)

• KU Medical Center to receive $5 million from state legislature to build Kansas Brain Health Assessment Network (KUMC)

• Sunnybrook Announces $41-Million Gift to Advance Canada’s Global Leadership in Clinical Trials (Sunnybrook Foundation)

Commercial

• ResMed Acquires Noctrix for $360m (Michael West)

  • According to this analyst Noctrix is generating around $24m/year in revenue. What questions do you have about this exit? What does it signal to you?

• NeurAxis Expands Payer Coverage with Four New Medical Policies (Yahoo Finance)

• MintNeuro and Motif Neurotech Partner to Advance Miniature Brain-Computer Interface Therapy for Mental Health (PR Newswire)

• Precision Neuroscience™ Partners With UChicago Medicine Researchers to Advance Brain–Computer Interface Research (GlobeNewswire)

• SetPoint Medical Announces First Patients Enrolled in Pilot Study Evaluating Neuroimmune Modulation for Multiple Sclerosis (SetPoint Medical)

• IntraNerve Neuroscience and Piramidal form a strategic partnership to develop AI tools that rapidly analyze continuous EEG data for seizure, stroke, and brain injury detection in critical care settings (PR Newswire)

• NRx Pharmaceuticals Advances Robotic-Enabled Transcranial Magnetic Stimulation Combined with Neuroplastic Therapy for Military and First Responder Applications (Yahoo)

  • “A key objective of the NRx Defense Systems initiative is to develop robotic and artificial intelligence-enabled solutions that can be forward-deployed within military organizations without relying on a new layer of skilled medical professionals. The prototype is being developed in partnership with Zeta Surgical, Inc., whose AI-powered neuronavigation platform received FDA 510(k) clearance for TMS navigation in October 2025.”

• Nexalin Technology Advances Pivotal Clinical Trial of HALO™ Clarity Toward Q2 2026 Enrollment (Nexalin)

• Neurable Open for Business: Scaling Neurotechnology Adoption Through Global OEM Integration (BusinessWire)

  • This strikes me as both a big pivot for a “smart headphone company,” but also as an inevitable evolution into the broader tech landscape. What are your thoughts, questions, predictions about this trend?

• Neuvotion announces the upcoming launch of NeuStim as part of its AI-guided brain–body interface platform for stroke and spinal cord injury (PR Newswire)

• Zeto Introduces NeuroNotis™: An AI-Enabled Report with Human Review (PR Newswire)

• AHG announces initiation of world-class proprietary brain-computer interface R&D program, targeting the next frontier of human neurotechnology (PR Newswire)

• NeuroOne, Eden Prairie company, expands OneRF med tech to trigeminal neuralgia chronic pain disorder (TCB Mag)

• Connectome partners with football club Como 1907 (Connectome)

• MYndspan Opens Its Analysis Pipeline to Clinicians, MEG Labs, and Individuals Worldwide (Fitt Insider)

• Radial Expands to Seven Clinics with New Locations in Brooklyn and Spartanburg, SC(PR Newswire)

• Ilan Gur joins Renaissance Philanthropy as a Senior Fellow (LinkedIn)

• David Eagleman joins Subsense’s Scientific Advisory Board (Subsense)

• Phagenesis Appoints Former Medtronic Executive Stephen Oesterle, MD, to Board of Directors (citybiz)

Regulatory

• ANEUVO Receives FDA Clearance for ExaStim® (GlobeNewswire)

• Motif Neurotech Receives FDA Approval to Begin First Clinical Trial of its Therapeutic BCI for Treatment-Resistant Depression (Business Wire)

• CorTec’s Brain Interchange Accepted into FDA Total Product Life Cycle Advisory Program (TAP) – Third patient successfully implanted at Harborview Medical Center as NIH-funded stroke trial advances (Cortec)

• Expert panel support for breakthrough medical devices: pilot programme (EMA)

• CMS and FDA Announce RAPID Coverage Pathway to Accelerate Patient Access to Life-Changing Medical Devices (CMS)

  • Credit Where It’s Due: The RAPID Coverage Pathway (What the FDA)

• CMS proposes repeal of add-on payment path for breakthrough devices (MedTechDive)

• FDA Announces Real-Time Clinical Trials pilot (Marty Makary | HHS)

So many changes happening in Washington! I want to hear from you and your leadership team about the emerging programs above.

📌Community Board

🆕Pin your news - Highlight key deals, events, roles, or announcements!

• D44 Capital is launching a series of high-impact neuro summits. This will start with the Berkshires Brain Summit 2026 in June, and continue with gatherings on autism, neurotech, psychedelics, neurodegeneration, and other areas. Learn more

• ARIA: Massively Scalable Neurotechnologies - Apply by 11 May!

• WashU’s Neurotech Hub: Engineering Hidden in Plain Sight: Novel Foraging Behavior - Read more

Industry

• INBRAIN Neuroelectronics Completes Enrollment of World’s First-in-Human Study of Graphene Neural Interfaces for Brain Decoding & Mapping (Business Wire)

• Kneu Health shares poster at the AAN Annual Conference: Real-World Multicentre Smartphone Based Tracking for Parkinson’s Disease (Kneu Health)

• Nexalin Announces Peer-Reviewed Publication with Neuroimaging Data in Psychotherapy and Psychosomatics Highlighting Brain-Network Effects and Clinical Improvement in Chronic Insomnia (Nexalin)

• ONWARD Medical Announces First Participant Enrolled in

  Global Pivotal Study Evaluating ARC-IM System to Address

  Blood Pressure Instability After Spinal Cord Injury (ONWARD)

• Longevity Sector Update: Feb-April 2026 (Mary Furlong & Associates)

• How AI Will Reshape Computer Systems by 2035: A Jeffersonian Dinner in San Francisco About Our 10,000x Future (CRA Industry)

• The Imitation Game (Grounded Neuro)

• Flow: Depression at home: FDA clears first at‑home brain stimulation device for major depression (New York Times)

• The Real World Burden of post-stroke Dysphagia (Phagenyx)

• Investors Sound Off on BCI Hype, Regulatory Risk, and the AI Gold Rush (Bio-IT World)

• Brain Computer Interface Stocks: 10 Plays Beyond Neuralink (InvestorPlace)

• New Peer-Reviewed Study Using BrainCheck Identifies Four Distinct Cognitive Trajectories in Patients Hospitalized for COVID-19 (Business Wire)

• Comphya: Safety and tolerability of a novel implantable neurostimulator to improve erectile function: a pilot study in patients with spinal cord injury (Journal of Sexual Medicine)

• Collaboration Connects Early Autism Diagnosis with High-Quality Outcomes-Driven Care Amid Industry-Wide Access Issues (PR Newswire)

• HealthTechConnex: Monitoring Cognitive Brain Function Before and After Spaceflight: Feasibility of Brain Vital Signs (Space: Science & Technology)

• Promises and performance in brain–machine interfaces: will AI be our saviour? (EPJ Special Topics)

• huMannity Medtec Fulfills Alfred Mann’s Medical Visions (Neurotech Reports)

• Extending Our Perception: What if we could build Hypersensory Intelligence – integrated systems of sensing and AI designed to tackle the world’s most critical challenges? (ARIA)

  • Related: How ARIA Is Reimagining Health With Radical New Approaches (Wired). ARIA is one step ahead of ARPA-H….

    

• Neurotech Investing Into 2035 (Delphi Ventures)

  • Solid report. “The surge in capital interest isn’t coming from a single thesis. Sovereign wealth funds, defence agencies, consumer electronics strategics, clinical medtech incumbents and pure-play technology VCs are all deploying capital into the same space, each drawn by a different facet of the opportunity. The clinical value, the platform potential, the hardware moats, the data assets, the national security implications, or just the pure speculation in a market driven by frontier science. Neurotech is fundamentally interdisciplinary, sitting at the intersection of materials science, semiconductor engineering, clinical medicine, software and AI simultaneously. But the same structural forces that make neurotech compelling also make it treacherous to invest in without discipline. Category-defining infrastructure and well-funded science projects are hard to differentiate at first glance.”

Neurotech.TV

• Can We Engineer Dreams? with Adam Haar Horowitz (David Eagleman)

• A High-Resolution Atlas of the Developing Human Brain (Johns Hopkins Medicine)

• The Swiss Tech Helping Paralyzed People Walk And Thrive Again (Core Memory)

• Living with BCI - Nathan Copeland (Julius Moorman)

• How to teach AI empathy using brain signals (Existential Hope)

New Jobs added in the last two weeks from LVIS, Paradromics, Synchron, Nerualink, Sharper Sense, Howard Hughes Medical Institute, Blackrock, Saluda Medical, AXION, Abbott, Quiver, LivaNova and more!

Society

• Why do discussions about ‘brain health’ ignore mental illness? (STAT | LinkedIn)

• Brain science needs a new social contract (Dana Foundation in Nature)

• Aligning Incentives to the Future of Science (Dana Fdn)

• Sergey Brin’s Family Office Takes Over Brain-Focused VC Fund (Bloomberg)

• Europe needs new rules for wellness neurotech devices (CfG)

• A Synthetic Biology Pioneer Has Left Us: Remembering J. Craig Venter (1946–2026) (SynBioBeta)

Research

• Do octopus brains work like humans’ — or is there another way to be smart? (Nature)

• Solving the problem of inception: a cross-species perspective on strategies for a mechanistic refinement of intracortical microstimulation (Journal of Neural Engineering)

• Analog Cognition and Consciousness (PsyArXiv)

• Dr. Martijn Figee on the Psychiatry-Neurosurgery Collaboration that is Changing Everything (Frontier Psychiatrists)

• Reporting from China highlights growing clinical use of brain–computer interface systems in stroke and motor recovery rehabilitation programs, with hospitals using non-invasive EEG-based BCIs to translate patients’ movement intentions into limb activation and strengthen brain–body connectivity (People’s Daily Online).

• Coverage of Columbia Engineering’s BISC platform details a high-density, flexible brain–computer interface chip with 65,536 electrodes and integrated recording, stimulation, and wireless power/data, demonstrating chronic recordings in large-animal and intraoperative human settings and underscoring the trend toward thin, high-bandwidth cortical surface BCIs (In Electronics & Design).

• Predictive coding with spiking neural networks: A survey (Neural Networks)

• A survey on neuro-mimetic deep learning via predictive coding (Neural Networks)

• Artificial neurons successfully communicate with living brain cells (Science Daily)

• UW research team applies game theory to create a new framework for neural interface design (U of Wash)

• Platform Bridges Gap to Human Brain Therapies (U of Wash)

• Fuel for thought: A brain fit for the 21st century is one that understands – and respects – its own bioenergetic foundations (Aeon)

• Wearable Technology and Its Role in Neurologic Care (Neurology)

  • Yawn. Milquetoast, nothing new. Where’s the brainy leadership here?

• A standardized framework for reporting participant-experienced events in low intensity focused ultrasound neuromodulation (Brain Stimulation)

• Effects of non-invasive spinal cord stimulation on autonomic function in individuals with subacute spinal cord injury: A pilot clinical trial protocol (PLOS One)

• Long-Term Outcomes of Subthalamic Nucleus and Globus Pallidus Interna Deep Brain Stimulation for Young-Onset Parkinson Disease (Neurology Clinical Practice)

• Fascia: The Fabric That Listens: (NeuroChronicle)

• The Imitation Game: Foundation models in neuroscience: representational alignment versus mechanistic understanding (Grounded)

That’s a wrap! What did we miss? Let me know for next time.
Did you know you can unlock free membership by referring your friends and colleagues to Neurotech Futures?

On the Reg is a new initiative to spotlight strategy, opinion, and insights from the neurotech field’s evolving regulatory landscape. It’s written for and by commercial leaders and experts from our audience of engaged readers.

Why now? Regulatory strategy faces a sea change. In our sudden new normal, influencer policymaking, revolving door reforms, overdue overhauls are all transforming decades of federal precedent…and that was just over the course of the last week.

That’s not to mention dramatic staffing cuts, ongoing leadership changes, high-profile company warnings, payment reforms and retreats, new purses for R&D, and new geopolitical priorities from county to country level that implicate neurotechnology’s commercial trajectories directly and systemically.

The safest bet is that there will be more changes a-coming.

So, the immediate goal of this newsletter is to establish a timely resource to curate, solicit, and broadcast regulatory intelligence and bold perspectives. I want to keep an ear to the ground on what’s happening in DC (and beyond) and I’m turning to this newsletter’s growing ecosystem of experts to help.

Longer term and beyond what’s published here, this work will catalyze a deeper network of ideas and relationships in support of the neurotech industry’s collective opportunity to advance commonsense policy reforms in the coming years. Or months.

Does this strike a chord? Hit reply and tell me about it.

For now, let’s kick off this inaugural issue.

Table of Contents - April 2026

• Q1 2026 Regulatory Roundup

• FDA and CMS Propose RAPID Collaboration to Bridge Initial Coverage Challenges for Novel Medical Devices

• FDA Update: Total Product Life Cycle Advisory Program (TAP)

• Inside the FDA’s TAP Program: Perspectives from a Program Advisor and a Chief Product Officer

• FDA’s 2025 Neurology Performance in Review

• CDRH Hiring Needs Are Bigger Than the Numbers

• Moving from “What Can We Measure?” to “What Actually Matters?”

• Sana Health’s New Neurology Niche

• FDA’s Premarket Guidance on Weight Loss Medical Devices

A huge thanks to our guest contributors this issue: Elle Winn and Susan Lubejko PhD at Mittal Consulting, Blythe Karow at Karow Advisory Group, Steve Silverman at The Silverman Group, & Vivek Pinto at Precision Neuroscience.

Q1 Regulatory Roundup + Invitation To Collaborate

By Naveen Rao

For over two years I’ve gathered thousands of Notables related to global regulatory agency news, clinical studies, reimbursement milestones (or pitfalls), and various related news, trends, topics, and developments.

To spare myself from creating another mega snapshot report, this newsletter will contain bite sized readouts, chop-ups, or *ahem* collaborations, to dive into specific questions and ideas by market, program, stage, or other angle.

To kick this off, let’s start with a basic roundup + review of the first quarter of 2026’s regulatory news, with some April headlines stuffed in too.

PMA: LivaNova - Sleep apnea (device); Neuracle - Motor Control BCI (device); Neurolief - Treatment Resistant Depression (wearable); NeuroPace - Idiopathic Generalized Epilepsy (device + digital); Nexalin - Alzheimer’s Disease (neuromod) ; Neuracle - Motor Control BCI (device)

deNovo: Neuropacs -Parkinsons Diagnostic (software); Neurovalens - weight management + EU/UK (neuromod); Sana Health - Pain Relief (neuromod)

510k: ANEUVO - Spinal Cord Rehab (neuromod) BlueWind - Urinary Incontinence (device); Cala - Essential Tremor (wearable); Empatica - sleep monitoring (wearable); Encora -Essential Tremor (wearable); Focused Cryo - Cryoablation (device); Intellidrop - Physical AI for ICU (software); Medivis - AR Neurosurgery; Neuroeventlabs - Seizure monitoring (software); NaoX, in-ear EEG (wearable); SonoMotion - Kidney Stones (FUS); Soterix Medical - Major Depression (TMS); Zeto - Outpatient Epilepsy (device + digital)

Pivotal Study: Click Therapeutics - Migraine (digital - sidenote what does the FDA’s publishing this data “mean”?); Neuspera - Urinary Incontinence (device); Spark Biomedical - Heavy Menstrual Bleeding (Neuromod); Synchron - motor control BCI (device)

Breakthrough Designation: Ceribell - Stroke Monitoring (device + digital); Cortec - Stroke Rehab BCI (device); NeuSonorous - pulsatile tinnitus (nasal stent…pick your brain, is this neurotech territory or not?); Nia Therapeutics - memory loss (device); Revision - Vision BCI (device); Pathmaker Neurosystems - ALS (Neuromod)

First in Human: Cortec Neuro - Stroke Rehab BCI (device); INBRAIN Neuroelectronics - Motor Control BCI (device); Phantom Neuro - Prosthetic Hand BCI (device);

IDE: Motif Neurotech- Psychiatric BCI (device)

• I labeled these by market focus and modality in parentheses, with ‘device’ generally meaning implanted. All thoughts, notes, ideas welcome.

• Tell me what news I missed in Q1. And please send me your reg & commercial news directly to free us from the tyranny of LinkedIn’s algorithm.

• Inform this newsletter’s content: What questions, ideas, views, angles of regulatory analysis would be useful for you and your team?

FDA and CMS Propose RAPID Collaboration to Bridge Initial Coverage Challenges for Novel Medical Devices

By: Elle Winn and Susan Lubejko PhD, Regulatory Affairs Specialist II at Mittal Consulting, where the full version of this article appeared.

On Thursday April 23, the United States Food and Drug Administration (FDA) and Centers for Medicare & Medicaid Services (CMS) announced a new, expedited Regulatory Alignment for Predictable and Immediate Device (RAPID) coverage pathway for certain FDA-designated Class II and III Breakthrough Devices. The implementation RAPID is expected to streamline the planning of outcomes for clinical studies to ensure FDA-authorization also satisfies requirements for Medicare coverage. RAPID is expected to substantially shorten the time required to obtain proposed coverage determinations under current reimbursement frameworks.

This is the latest of several attempts to expedite coverage pathways for novel medical devices. In 2021, the short-lived Medicare Coverage of Innovative Technology (MCIT) pathway was designed to accelerate coverage by providing immediate, automatic Medicare coverage for up to four years. MCIT was repealed after only 10 months due to concerns of insufficient evidence standards, limited executive authority for CMS, and concerns about delegating Medicare coverage decisions to the FDA.

In 2024, the Transitional Coverage for Emerging Technologies (TCET) program was set up as a voluntary path for FDA Breakthrough-designated medical devices to secure reimbursement. TCET relies on the National Coverage Determination (NCD) and Coverage with Evidence (CED) frameworks to judge whether the device is “reasonable and necessary” or provide conditional coverage while additional clinical data are collected to support a future coverage decision. The TCET pathway is highly selective and competitive to obtain coverage. A disadvantage of the current TCET pathway is coverage delays due to gaps between FDA authorization and Medicare coverage determination.

2026: Under RAPID, CMS will join discussions with FDA and sponsors to identify what clinical outcomes matter for Medicare patients in medical device clinical studies, so sponsors are equipped with the knowledge of what evidence will satisfy both FDA and CMS requirements. Ultimately the program will aim to arm devices with a proposed National Coverage Determination (NCD) the same day as they receive FDA authorization.

Eligibility includes Class II Breakthrough-designated devices which are also enrolled in the FDA’s Total Product Life Cycle Advisory Program (TAP), as well as Class III Breakthrough Designated Devices regardless of TAP enrollment. All devices must be the subject of an Investigational Device Exemption (IDE) clinical study that enrolls Medicare beneficiaries such that both FDA and CMS can weigh in on the outcomes to be addressed in the study. More here.

Following the proposed NCD, there will be a public comment period, leading to potential final coverage in a time frame of a couple of months, rather than years as has been the historical median.

Founders and Leaders in BDD/TAP pathways: Hit reply to get me up to speed on what this means for your business, and what you want (and don’t want) to see in the new RAPID program.

FDA Update: Total Product Life Cycle Advisory Program (TAP)

Published by the FDA on April 23, 2026

As of April 23, 2026, there are 122 devices enrolled in the FDA’s TAP Pilot.

On May 1, 2026, TAP is expanding to include the Division of Renal, Gastrointestinal, Obesity and Transplant Devices (DHT3A); and the Office of Surgical and Infection Control Devices (OHT4).

On July 1, 2026, TAP is expanding to include the Division of Implantable Dental Devices, Restorative and Surgical Dental Devices, Ear, Nose, and Throat Devices (DHT1B), Division of Anesthesia Devices, Respiratory Devices, and Sleep Disordered Breathing Devices (DHT1C), Division of Obstetrical and Reproductive Health, Gynecological and Surgical, Urological, and Incontinence and Female Urological (DHT3B); Division of Injection Devices, Infusion Devices, and General Hospital Devices (DHT3C), and the Office of In Vitro Diagnostics (OHT7).

An independent third-party assessment of the TAP Pilot is available here.

Inside the FDA’s TAP Program: Perspectives from a Program Advisor and a Chief Product Officer

By: Blythe Karow, Founder & Principal, Karow Advisory Group, and Editor, The Device Files, where the full version of this article originally appeared.

The Total Product Life Cycle Advisory Program, or TAP, launched in January 2023 as part of the MDUFA V reauthorization, the five-year user fee agreement between FDA and the medical device industry that runs through September 2027. It is a voluntary program run by FDA’s Center for Devices and Radiological Health (CDRH), and its stated mission is to reduce the time and cost of getting from concept to commercialization for breakthrough devices.¹

Eligibility is specific. A company must hold an FDA Breakthrough Device Designation, must not have submitted a pre-submission meeting request after receiving that designation, and must still be early in development with no pivotal trial underway. The type of technology eligible is also narrowly scoped. Currently covered areas only include cardiovascular, neurological and physical medicine, radiological health, ophthalmology, and orthopedics. Combination products are also excluded.

After applying, companies receive an enrollment decision within 30 days, and soon after the program gets going! As of mid-2025, 93 devices were enrolled with targets to reach 325 by the end of FY2027.²

Subscribe to Blythe’s (excellent) Substack, The Device Files, to learn about one founder’s experiences with this program, what happens after MDUFA V, and much more.

The Device Files: From Concept to Commercialization

Inside the FDA’s TAP Program: Perspectives from a Program Advisor and a Chief Product Officer

Did you know that fewer than 10% of products that receive FDA Breakthrough Device Designation ever actually make it to market? Well, if you’ve been a loyal reader of The Device Files for a while, you might have already heard that statistic once or twice…

Read more

3 months ago · 6 likes · Blythe Karow

FDA’s 2025 Neurology Performance in Review

By: Susan Lubejko PhD, Regulatory Affairs Specialist II at Mittal Consulting

In late February, FDA’s medical device review branch, the Center for Devices and Radiological Health (CDRH), published its updated performance data for the prior year. 2025 brought a change in administration and very public concern related to reductions in workforce at FDA. Despite a reported reduction in workforce of ~20%, the numbers encouragingly show that the CDRH scientific review teams themselves were largely insulated from these cuts. Nonetheless, real concern remained about CDRH’s continued device review efforts with less support staff and during a turbulent era. So, how did CDRH’s performance fare?

For manufacturers in the neurological devices space interacting with CDRH’s Office of Neurological and Physical Medicine Devices (OHT5), here’s how the metrics shake out: 510(k)s - Despite Fiscal Year (FY) 2024 to FY 2025 showing a significant increase in the number of neurological 510(k)s received (up 30%), interestingly, OHT5 reviewers processed 510(k) submissions quicker with ~23% shorter review times on average (120 days in FY 2025 vs. 156 days in FY 2024). De Novos - OHT5 received about the same number of De Novos for novel Class II devices in FY 2024 and FY 2025 with a small decrease in average days to decision (229 days to 210 days). This trajectory is especially encouraging for manufacturers given that FY2023 boasted an average of 287 days, showing that FDA has dedicated specific attention to pushing novel device submissions through in a timely manner.

PMAs - This trend does not continue for the highest risk devices reviewed by OHT5, which saw an ~8% increase in total days to decision from 298 days to 320 days in FY 2025. However, 2 of the 6 devices reviewed in FY 2025 are still in progress, meaning these numbers could change in future updates from CDRH as files are closed out and the metrics reflecting submissions made in 2025 are updated.

Overall, the metrics show that OHT5 has consistently met their review timelines this past year. For 510(k)s and De Novos, there appears to be a positive shift regarding the time during the review period spent with the manufacturer dealing with FDA’s additional requests for information, with that time decreasing by nearly 40%. Neurological device manufacturers interested in submitting to the FDA in 2026 are likely to benefit from consistent timelines and possibly less burdensome FDA requests during their review.

CDRH Hiring Needs Are Bigger Than the Numbers

By: Steve Silverman, President of The Silverman Group and Editor at What the FDA, where the full version of this article originally appeared.

From September 2024 to January 2026, CDRH lost about 20% of its workforce.

The damage was concentrated in areas where CDRH needs depth, such as AI and digital health. CDRH’s science and engineering office, which reviews complex technologies, lost about one-quarter of its staff. The April firings made things worse, gutting the offices tasked with recruiting, onboarding, and training staff. Into this vacuum, Commissioner Makary announced that FDA will hire more than 1000 new employees. Part of those hires must go to CDRH, commensurate with its losses and technical needs.

Hiring is central to MDUFA VI negotiations. Industry agreed to pay for CDRH hiring under MDUFA V, but the Trump administration fired many of those hires and industry now demands accountability. FDA has acknowledged the “shared intent to hire . . . additional review staff” without disclosing the details or accountability measures behind that pledge.

Read Steve’s full perspective and recommendations for Device Leaders. Subscribe to his Substack, What the FDA, for more Beltway analysis.

What the FDA?

Does CDRH’s Review Engine Need a Tune-Up?

CDRH’s device review numbers look good, especially after FDA lost a fifth of its workforce last year. But the data obscure a more complicated story – one that device executives can’t afford to misread…

Read more

3 months ago · 3 likes · Steve Silverman

What the FDA?

FDA’s AI Device Guidance Is Stuck in Draft. That’s a problem.

FDA published draft guidance on AI-enabled device software functions in January 2025 and comments closed last April. Meanwhile, FDA cleared almost 300 AI/ML devices last year (a record), but the AI guidance remains unfinished. Worse, CDRH’s 2026 guidance agenda…

Read more

2 months ago · 5 likes · Steve Silverman

Moving from “What Can We Measure?” to “What Actually Matters?”

By: Vivek Pinto, PhD, MBA, Director of Medical Affairs at Precision Neuroscience & Co-Lead of Clinical Endpoints, iBCI-CC, Former FDA Division Director

As of Q1 2026, a defining shift in how FDA and neurotech leaders approach clinical validation is no longer coming; it is here. For years, companies defaulted to available outcome measures for understandable reasons: prior use, ease of administration, some degree of validation, and comparability to existing literature. The consequence is predictable: we measure variables that don’t reliably translate into meaningful improvement in patients’ lives. This technology-first approach carries real risk. Not just to patients, but to market authorization, reimbursement, and clinical adoption. Clinical meaningfulness is paramount.

CDRH is doubling down on the Patient-Focused Drug Development (PFDD) guidance series. In Q1, I’ve seen these tools gain traction at conferences and within our iBCI-CC work, across Medical Devices and beyond. The message is consistent: patient experience data isn’t a supplement to your clinical evidence package; it reveals what matters to patients. It’s the foundation that tells you whether you’re measuring the right things at all. The standard has shifted from hitting endpoints to hitting the right endpoints. That distinction matters for every design decision upstream of your pivotal study.

Before locking your clinical trial design, apply Design Thinking to identify what actually matters to users before you decide what measures to use, just as you do for product design when deciding what to build. Don’t adopt an off-the-shelf outcome measure just because it’s “standard.” Capture the aspects of health most meaningful to your target user and then determine how to measure them. Grassroots engagement with patient communities throughout your product lifecycle isn’t a “nice to have”; it’s a prerequisite for regulatory and commercial success, and it is what truly makes a difference in patients’ lives.

Sana Health’s New Neurology Niche

By: Susan Lubejko PhD, Regulatory Affairs Specialist II at Mittal Consulting

Awarded in early 2026, FDA’s De Novo clearance for Sana Health’s Sana Device (DEN250005) breaks the regulatory mold for neurological and pain-treating devices. Compared to previously cleared medical devices for pain, Sana Health’s goggles that produce audiovisual cues at certain frequencies work at the brain level, not at the site of the pain, and set a regulatory precedent for a class of adjunct pain-relieving devices that will not require future FDA premarket sign-off. More on the impact for manufacturers entering the pain field below:

Most of the time, FDA-cleared pain modulating devices are administered locally or in the nerves on the way to the site of pain; however, the Sana Device works through a brain modulation technique. This means that instead of requiring a different device for new types of pain or at new sites in the body, audiovisual devices could cover patients with many pain etiologies.

Supporting this same concept, Sana Device’s clinical study (NCT04280562) recruited patients with a variety of pain types. Ultimately, the active treatment compared to sham demonstrated staying power past the end of the treatment cycle. However, the effects in the relatively small number of subjects were modest. This is probably why FDA required the device to be used as an “adjunct” to other concurrent treatments.

The most interesting regulatory revelation in Sana Device’s story is that FDA classified this device (and therefore others following under the new regulatory precedent it sets) as a Class I, low risk medical device. Most other devices indicated for primary pain treatment are Class II or III devices that require a premarket submission to the FDA. Usually, manufacturers using the De Novo pathway make the argument that their device should be Class II. In these cases, the manufacturers themselves set the rules for other devices entering their category, which may allow for the strategic setting of higher barriers to entry for competitors by increasing testing and documentation burden. This moat digging is not available to Class I 510(k)-exempt devices that follow basic registration with the FDA but typically aren’t required to go through a premarket submission.

For manufacturers working on audiovisual tech for pain, this is great news - Sana Health did the work to establish a new category with the FDA and now the Agency will not require a submission for other new devices in this niche before hitting the commercial market.

FDA’s Premarket Guidance on Weight Loss Medical Devices

By Naveen Rao

FDA’s March 2026 FDA guidance on “Medical Devices with Indications Associated with Weight Loss – Premarket Considerations” is relevant for neurotech startups pursuing treatments in indications for “weight loss, weight reduction, weight management, or obesity treatment.” It includes a dedicated product code “PIM – Neuromodulator for Obesity.”

This guidance suggests the FDA is tightening evidentiary and safety expectations for any neurotech that crosses into formal obesity or weight‑loss indications. The guidance reinforces the need for robust and specific clinical endpoints (e.g., % total body weight loss, durability, and impact on cardiometabolic comorbidities), alongside a structured benefit‑risk framework that explicitly weighs modest but sustained weight loss against device‑related adverse events.

It also signals that the agency will scrutinize non‑invasive neurostim platforms under the same paradigm as more invasive weight‑loss devices, including expectations around device description, labeling, biocompatibility, software, and MR safety, even if the device is external and prescribed. This will raise the bar for clinical trials, patient‑risk disclosures, and regulatory‑strategic planning across the sector.

Neurovalens, who received FDA de novo approval last December, offers an example of which approaches are implicated in this new guidance. Repurposing this great reporting from MassDevice: “Modius Lean, the latest offering from Neurovalens, helps manage weight by delivering an electrical pulse to the brain for a period of 60 minutes before bed. Users can take part in other activities, like watching TV or reading, while this occurs. A clinical trial of 241 overweight and obese adults found that participants who used Modius Lean experienced a clinically meaningful reduction of 13% in visceral fat over six months while preserving lean muscle mass.

With de novo clearance, Neurovalens can now begin selling Modius Lean directly to people in the U.S. with a prescription. The company now plans to turn to new clinical trials for Modius in other conditions. It also picked up an FDA nod for its Modius Sleep device for treating insomnia in October 2023 and launched it last year. It then received FDA clearance for Modius Calm for anxiety in April 2024, The company has also raised approximately £20 million (nearly $27 million) to date, including $8.1 million earlier this year. It currently has the system pending approval for post-traumatic stress disorder (PTSD).”

Weigh in: Does this guidance suggest more neurotech companies will enter weight loss category, or fewer?

That’s a wrap!

Thanks again to our contributors for helping launch this inaugural edition.

Hit reply and let me know: What regulatory headlines are most important for founders, commercial leaders and investors to understand, and why?

• Tell me about specific company approvals or clearances, or related trends analysis of markets, modalities, sectors you want to see covered.

• Ditto for program level analysis and interpretation across FDA, CMS, other agencies.

• Yes, I am interested in covering more global market developments from Europe, Asia, and all other markets. No, I cannot do this on my own so get in touch if you want to collaborate.

Thanks for reading and sharing with your colleagues.

You’re among the first to know about this! So if you’re in town - or can be - act fast and register to join u…

Read more

Neurotech news has been springing up all month, with commercial activity accelerating around the world. Here’s what I tracked over the last two weeks.

• Fresh fundraising news by Beacon, Neuroclues, Egra, Indivi.io, and Connectome Health, as well as new fund announcements from Heka and Ground Effect.

• The braintrust behind neural dust launched Epia Neuro a BCI platform for Stroke. Precision’s tech leadership is taking on a new focus. Bioness bought a neurotech asset. Cala, Zeto, Cortec posted FDA news. Synchron and Phantom both got approvals for key studies.

• Industry coverage on Science Corp’s biohybrid array, thought to text plays from AlterEgo and Think2Switch, progress in Alzheimer’s from Positrigo, Predictom, Sinaptica, Nexalin. As always, many other papers, interviews, and announcements.

• Ethics: Karen Rommelfanger takes on an exciting new role, while neurotech permeates the discourse across war, urban planning, women’s health, community research, and health equity. (Notice I didn’t call it “neuroethics,” just ethics. That was on purpose. Come at me, dweebs! )

• Groundbreaking research is piling up to the ceiling as always: Neuroimaging, TMS, FUS, vision. Brain studies on Movement, Aging, Migraines, TBI, PTSD.

“And More…” Things are shifting here at Neurotech Futures. The work is taking me offline, outside the bounds, to secretive science labs, private forums, and into the evenings and weekends of my life.

• Last night at a private founders happy hour I put onto the table four neurotechnologies I’ve accumulated in my travels: a microelectrode array to stimulate and record single neurons in vitro, an implantable BCI array from a leading startup, wearable EEG headphones (ditto), and my smartphone. I asked to the group to rank these “BCI” from most to least to most powerful, and then from most to least ethical. We didn’t reach consensus, and that’s the point.

• This past weekend I took my four year old to San Francisco’s Frontier Tower to visit students participating in the Global Neurohack. It was so inspiring to see the next generation of builders and founders from around the country and world (Germany, Singapore, Switzerland, UK). Congrats to the winners, shout out to all attendees & generous sponsors who made this possible. And a most special thanks to Darius, Morgan, and Abby/Thanos for helping me babysit on a rainy Saturday.

• This platform is changing and expanding in real time, with strategic partnerships, alliances, and content development underway. The team has been growing behind the scenes. An investor-founder connection I made turned into a signed check to the company! LFG. Referred candidates are getting job offers. Leaders have approached me with big opportunities I can’t talk about. New events are coming very soon. Stay tuned and upgrade to get on the inside track and support the work. I am transparently figuring this all out as I go, so join the adventure.

As always, hit reply to share news I missed and your ideas for how we can build together. Pardon my slow replies, I’m a bit behind on everything!

Have a great weekend ahead -

👋🏽 Hi, I’m Naveen. I believe brain health is human health. You are one of the 4,205 readers of my biweekly reports on emerging neurotech markets.
Operators: Upgrade today to get Signals, Insider, and Perks.
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📲 Connect here: email | LinkedIn | X | bluesky | Click ❤️ to amplify!

• PL Neuro: Protocol Labs releases BCI Roadmap Series - Read Roadmap1: Smoothing the Path to Clinical Revenue. Bonus: A TWO HOUR chat with Max Hodak in Neurotech.TV.

• Resonant Link Medical: Curious what separates what’s exciting from what’s bankable in healthcare AI? Catch the 1st AI-focused healthcare VC on Resonant Link Medical’s latest podcast episode.

• NANS: NANS Joins Multisociety Advocacy on Trigger Point Injection Policy - Read More

• TTP: What’s ‘good enough’ for early clinical studies? - When you’re in the middle of development for a medical device, and the first clinical studies are on the horizon, compliance might seem a rather daunting prospect.

• Datwyler: Dry electrodes represent a significant leap in wearable technology, offering unobtrusive biopotential acquisition while presenting unique challenges like motion artifacts and high impedance. Discover how to optimize signal quality and leverage SoftPulse® technology in this featured webinar from BIOPAC Systems, Inc.

• BrainMind: Stay tuned for output from Asilomar! Follow BrainMind’s LinkedIn page to stay on top of all updates.

Funding

• Beacon announces extension to bring Series B funding to $97M (Linkedin)

• neuroClues secures €10M Series A led by Teampact.ventures, White Fund SA and the EIC Fund (LinkedIn)

• EGRA raises a $5.5M Pre-Seed Round (Linkedin)

• Connectome Health raises 2 million USD pre-seed round (Linkedin)

• Leclercq American Capital LLC invests in Indivi.io, a Swiss specialist in digital biomarkers for neurology (Eurozone)

• M2D2 $200K Challenge Names 2026 Pitch Contest Winners (UML Press Release)

• B.C. not-for-profits launch venture funds to turn research into revenue (BIV)

• Newfund raises €60m for Heka, a 60 million fund dedicated to braintech (Sifted)

• Ground Effect Ventures launches new fund focused on neurotech and “the convergence of physical systems, biological signals, and applied intelligence” (Linkedin)

Commercial

• Epia Neuro Launches to Develop Intent-Driven Neural Technology to Restore Function After Stroke and Address Cognitive Decline (Business Wire | Wired)

  • Stay tuned for more insights from my recent conversation with founders Michel Maharbiz and Gil Mandelbaum.

• Precision Neuroscience™ Appoints Craig Mermel as Chief AI and Data Officer (Globe Newswire)

• Bioness Medical Acquires the Portable Neuromodulation Stimulator (PoNS®) System (Bioness)

• Cerevia Neurosciences announces appointment of Dennis Cardoza to Board of Directors (LinkedIn)

• Motif appoints excited to welcome Amanda Geisinger as our Director of Lived Experience (Motif)

• Arc Institute partners with The OpenAI Foundation (Linkedin)

Regulatory

• Cala wins FDA nod for next-gen wearable neurostim tech for essential tremor, Parkinson’s (Mass Device)

• Zeto Announces FDA 510(k) Clearance of Zeto New Wave™, Advancing Efficiency in Outpatient EEG (PR Newswire)

• Neuropacs’ AI-based software wins FDA nod to differentiate degenerative diseases (Firstword HealthTech)

• CorTec Receives FDA Breakthrough Device Designation for Its Brain Interchange System in Stroke Rehabilitation — the First BCI Worldwide Designated for Stroke Motor Rehabilitation (Cortec)

• Synchron has received permission to start INTENT, their third clinical trial on the Stentrode BCI (LinkedIn)

• Phantom Neuro announces approval of first-in-human clinical study, CYBORG, for the Phantom X system in Australia (LinkedIn)

• CMS Eyes End to Streamlined Path For New Technology Payments (My Strategist)

• American Brain Coalition Statement on the President’s FY2027 Budget Proposal (ABC)

• Request for Information on Draft NIH Resources to Support Implantable Device Trials (NIH)

  • Draft resources here. Deadline May 25 2026

• Shuren and Former FDA Colleagues Launch New Firm (Market Pathways)

📌Community Board

🆕Pin your news - Highlight key deals, events, roles, or announcements!

• Neurofounders+ launches as new premium membership with exclusive articles, recurring data snapshots, in-depth reports, a Startup Map+ with 300+ curated company entries, and an Investor Map tracking 150+ funds. Learn more and sign up today: www.neurofounders.co/plus/sign-up

• GABA releases first edition of neurotech community journal (Linkedin)

• Human + Tech Week is coming to San Francisco, with a health conference on May 13, 2026. Stay tuned for early registration to our exciting partner event (Insiders will see it first, next week…)

Industry

• Max Hodak’s Science Corp. is preparing to place its first sensor in a human brain (TechCrunch)

  • “Unlike a Neuralink device, which is inserted directly into brain tissue, Science’s sensor will be implanted inside the skull but rest on top of the brain. Possibly because of that distinction, the company says it doesn’t plan to seek FDA approval for these trials, arguing the tiny device — which contains 520 recording electrodes packed into an area the size of a pea — poses no significant risk to patients.The team’s plan is to find patient candidates who already require significant brain surgery, like stroke victims who need a piece of their cranium removed to reduce the impact of brain swelling.”

• Axoft launches new clinical research study with Mass General Brigham, bringing the total number of implantations using Axoft’s Fleuron™ probes to 11 patients across three different clinical sites (LinkedIn)

• Kitea Health: Long-term brain pressure monitoring via a discrete microimplant; a first-in-human safety and initial efficacy trial in adults and children with hydrocephalus (Nature Communications)

• Mount Sinai Enrolling Patients in DoD-Funded Clinical Trial of Drug-Free Neuromodulation Therapy for Postpartum Depression (FirstWord)

• The Memo: Sinaptica Therapeutics Advancing Precision Neuromodulation for Alzheimer’s Disease (Life Science Market Research)

• Nexalin Announces Peer-Reviewed Study Showing the Company’s DIFS™ Technology Reduced Self-Injury and Depression Symptoms in Female Adolescents (Nexalin)

  • Nexalin Advances FDA Alzheimer’s Strategy Following Landmark Leadership Meetings in the U.S. and China (Nexalin)

• Recruitment milestone reached in AD-RIDDLE pilot study on digital cognitive assessments (AD Riddle)

• At Home Alzheimer’s Detection Takes a Leap Forward (Predictom)

• Positrigo Launches the BrainPET Accelerator Program in the U.S. (Positrigo)

• Telepathy Machine? Here’s What MIT’s AlterEgo Wearable Actually Does (CNET)

• From Lab to Living Room: Think2Switch™ Lets Users Control Devices With Their Thoughts (Possibility)

• Colorado’s First Implanted Brain–Computer Interface Surgery Marks a New Era in Neurologic Care (PR Newswire)

• Subsense: a Brain Computer Interface Technology, powered by NanoParticles. Talking with founder and CEO Tetiana Aleksandrova (The SF Podcast)

• Imaginostics: Health Moonshot Update: Imaginostics Is Making the Invisible Visible in Vascular Health (Startup Health)

• Pioneering gammaCore nVNS Study for PTSD Enrolls First Patient (Clinical Trial Vanguard)

• Mint: Chips for the Brain: Modular Semiconductors for Neural Interfaces (State of the Future)

• 22 years of Brain Science: what CoSyNe tells us about the evolution of Neuroscience (Grounded)

  • Excellent meta-analysis of neurotech’s evolving role in AI research and beyond.

• Inside Minnesota’s med tech powerhouse: How Medtronic and its local ecosystem are building the future of healthcare (Fast Company)

Neurotech.TV

• ASPN Season 4, Episode 1 – Restoring Rest: The Noctrix Journey to Solve RLS (Linkedin)

• WATCH: Brain‑Computer Interfaces: Current Applications & Emerging Directions (Houston Methodist)

• Can Abbott’s connected neuromodulation platforms improve life for chronic pain and movement disorder patients?” – AbbottTalks / DeviceTalks podcast episode (DeviceTalks)

• Alzheimer’s Drugs Arrived Brain Scanners Didn’t with Jannis Fischer (Cruxx)

Society

• Georgia Tech Welcomes a Neuroethics Pioneer Karen Rommelfanger as a professor in Practice (GTech)

• Borg urbanism: emerging neural infrastructures of urban governance (Urban Geography)

• iBCI-CC releases second Annual Report highlighting progress over the past year, including key milestones, Workgroup activities, and collaborative efforts to advance the iBCI field (iBCI-CC)

• Who Owns Digital Thoughts? The Limits of Property Law and the 2025 UNESCO Recommendation on the Ethics of Neurotechnology (Stanford Law)

• Neurotechnology and the Governance of the Mind (GESDA)

• How neurotech companies navigate the grey zone: Neurotech between wellness and medicine part three (CfG) and part four: a proposal (CFG)

  • Check out these papers, please: CfG has become the world’s leading think tank on neurotech’s impact on society.

• Women’s Brains Can Help Unleash a $1 Trillion Opportunity (TIME)

• Your brain for sale? The new frontier of neural data (The Conversation)

• Why We Need Community-Based Participatory Research (CBPR) in Neuroethics (Neuroethics)

• A Roadmap to Neurologic Health Equity (Neurology)

• Pentagon launches living neural computer for drone navigation (Defence Blog)

  Neurotechnology and the Transformation of War’s Human Domain (Small Wars Journal)

Research

• ‘Digital sphinx’ raises questions about connectome models(Transmitter)

• Scientists identify ‘neural fingerprint’ of psychedelic drugs in the brain (Guardian)

• Cortical-limbic circuit dynamics of approach-avoidance conflict in humans (Nature Communication)

• Science’s Axon Terminal designed by Card79 Wins 2026 iF Design Award (Science)

• These Earbuds Have Eyes VueBuds integrate low-res cameras and visual AI as a smart glasses alternative (IEEE | Paper | Video)

• A new approach to brain health, one neuron at a time NPR

• Dose-response relationships in transcranial brain stimulation: Physics, physiology and mechanism (Science Direct)

• An international mega-analysis of psychedelic drug effects on brain circuit function (Nature Medicine)

• Flexible ultrasound array for subcortical brain stimulation in humans: a simulation study (Linkedin)

• A new study helps explain how the brain creates mental images (NPR)

• MIO: Towards Interactive Intelligence for Digital Humans (Shanda AI)

• A preliminary study of the efficacy of bimodal versus unimodal stumble recovery responses in a powered knee prosthesis (Wearable Technologies)

• High-Tech Magnets Offer New Hope for Veterans Battling Combat PTSD (US News)

• Testing new TMS targeting algorithms in an open label trial in a treatment-resistant depression population (Two preprints)

• Early cognitive screening for individuals on the dementia continuum: A novel approach amid current trends (Journal of AD)

• Low-intensity focused ultrasound to human amygdala reveals a causal role in ambiguous emotion processing and alters local and network activity (Neuron)

• Clinical Trial For Brain Cancer Treatment has Promising Results (Forbes)

• Neuroimaging-based subtyping of migraine identifies clinically distinct phenotypes (Cephalalgia)

• Study Links Executive Functioning to Physical Activity in Older Adults (Integrative Practitioner)

• Brain Creates “Vivid Worlds” During Total Collapse (Neuroscience News)

• A transcriptional program associated with neurotransmission in the living human brain (Molecular Psychiatry)

That’s a wrap! What did we miss? Let me know for next time.
Did you know you can unlock free membership by referring your friends and colleagues to Neurotech Futures?

Here is the latest installment of Signals, a members-only newsletter analyzing key commercial developments across the neurotech industry each month.

This edition covers some of the important developments last month in March 2026. Here’s what caught our eye.

• Nia Therapeutics FDA Breakthrough for Memory Loss

• Meta’s TRIBE model

• China’s Accelerating BCI Progress

• WHOOP’s funding as a consumer neurotech signal

• Paradromics’ new APEX Clinical Partnership Platform

• BrainSway’s growth and investment strategy

• Plus a special announcement for hardcore neurotech analysis junkies!

Given coverage of Science Corp across recent editions of Signals, we didn’t include their Series C or recent leadership news. But stay tuned for more on Science in the next issue of Representations later this month…

Let’s dive in.

Read more

Another deluge of commercial neurotech news carried on through a trio of major industry events over the last two weeks. LSI, OctaneOC, and Asilomar. I’ve just come home from the latter and my BrainMind is still spinning. Here are your notables for the back half of March.

• Nearly $100m in new capital to BCI, various neuromodulation plays, and wearables was dwarfed by a jumbo round to WHOOP and a super-duper-mega-jumbo round to OpenAI. Both NIH and DARPA posted relevant program calls.

• BCI’s March: StairMed secured funding from AliBaba, while Neuracle received governmental clearance for commercial use, two streams of China’s broader flood-the-zone BCI strategy. Ruten secured a small round while Araya, the Japanese federal moonshot program announced a new partnership and a new public program. Stateside, Paradromics advanced their clinical study with MGH and announced a new research platform with five new partners, while Neuralink and Science hired key clinical leaders.

• Partnership Season: EEG decoding platforms, Wearables, BCI, Prosthetics, Neuromodulation, and other players announced new partnerships. Distribution deals, two acquisitions, a new spinout, cross-indication capabilities, and executive appointments rounded out the fortnite’s commercial news.

• Regulatory News: Nia Therapeutics obtains FDA Breakthrough, while LivaNova secures a clearance in sleep apnea, with other approvals in the UK and China. The FDA issues new notices on patient preferences and an update on the TAP program.

• New health systems opening their doors and expanding their footprints around the US indicates the market for newer care models opening up across neurology and psychiatry alike. Meanwhile clinical progress from Keygrip, Fareon, Cognito, and various TMS plays.

• “And More” A spree of articles on neural organoids. Chinese Neurotech. Neuro-inspired Music, Dance, Ethics. Meta drops its new TRIBE model (which one executive at BrainMind event described to me as “invasive as hell”…) CoMind posts its first publications. New Journals. New research platforms.

Lastly make sure to scroll to our Community Board for student hackathons, and other events and opportunities worth a click. Fresh roles on our Job Board too! Major congrats to our colleagues at Neurotech Reports on their acquisition! Stay tuned for more collaborated content and event announcements from us in the coming weeks. Safe travels to all of you jetsetters and road warriors.

As always, Hit reply with your news, ideas, and feedback.

👋🏽 Hi, I’m Naveen. I believe brain health is human health. You are one of the 4,130 readers of my biweekly reports on emerging neurotech markets.
Operators: Upgrade today to get Signals, Insider, and Perks.
Engage: 🎟️Referral program | 💼 Job Board | 🗓️Event Calendar
Collaborate: Annual Partnership | Post Ads | Advisory Services
📲 Connect here: email | LinkedIn | X | bluesky | Click ❤️ to amplify!

• PL Neuro: Models to Markets: BCI, Neural Data, and Business Innovation in the AI Era - Read More

• Resonant Link Medical: RLM is hiring a Staff Power Electronics Engineer in the Cambridge, MA Office - Learn more and apply today!

• NANS: NANS Applauds Aetna for Revising Policy on Peripheral Electrical Nerve Stimulation for Pain Policy - Read More

• TTP: The role of algorithms in closed-loop neuromodulation - How hardware limits shape algorithm performance, and what makes closed-loop systems work beyond the lab. Read the full insight

• Datwyler: Join us in Mountain View, CA, June 10-11, 2026, at the TechBlick event, “The future of electronics RESHAPED.” Mattia Lucchini, Head of Venture Unit Wearable Sensors, will share insights on next-gen wearables as a window into internal physiological and mental states. Learn more and join us!

• BrainMind: Stay tuned for output from Asilomar! Follow BrainMind’s LinkedIn page to stay on top of all updates.

Funding

• WHOOP Raises $575 Million at $10.1 Billion Valuation to Advance Global Health Platform (BusinessWire)

  • WHOOP may not be your grandpa’s “neurotech device” but pay attention because this deal’s valuation, backers, and ripples will certainly influence the biometric wearables landscape. And while the aperture is open, on the AI side OpenAI just closed Silicon Valley’s largest ever fundraise: $122 Billion at a $852B valuation. What are your thoughts on ripples into neurotech valuations?

• Alibaba leads RMB 500m (~$75m USD) investment in BCI startup StairMed (KR Asia)

• Surf Therapeutics Reports Positive First-in-Human Data and Secures Additional Financing, Bringing Total Funding to $6M as Rheumatoid Arthritis Clinical Study Begins (BusinessWire)

• BrainsWay Completes Additional $6 Million Milestone-Based Investment in Neurolief Ltd. Following FDA Approval of Proliv™Rx System for MDD (GlobeNewswire)

  • BrainsWay Completes Revenue-Based Milestone Investment into Axis Integrated Mental Health (Yahoo)

• Mave Health Raises $2.1M to Launch Focus and Stress Regulation Wearable (BusinessWire | TechCrunch)

• Ruten raises $2m for BCI from Coral Capital (LinkedIn)

• Audicin lands $1.9M to make real-time nervous-system regulation a built-in layer for wearables and partner apps (Cision)

• Theta Neurotech has raised $1.75m pre-seed to monitor the brain and predict epileptic seizures (LinkedIn)

• CrossSense’s AI software for smart glasses wins £1m prize for technology to help people with dementia (Guardian)

• NINDS plans to release a HEAL Initiative RM1 focused on understanding the mechanisms of therapeutic medical devices to improve patient outcomes (Grants.gov)

• DARPA launches O-Circuit (Organoid Cytomorphic Intelligence Resulting from Convergent Understanding and Information Transfer) - Proposers’ Workshop April 10 (SAM)

• BCI Enters a New Funding Stage (Neurofounders)

  

Commercial

• Erika Ross Ellison joins Neuralink as Head of Clinical ( LinkedIn)

• Science Corp. Appoints Murat Günel, MD, as Medical Director for Brain-Computer Interfaces (BusinessWire | Science Corp)

• Cognito Therapeutics and Ochsner Health Launch Brain Health Collaboratory to Advance New Care Models for Alzheimer’s Disease (BusinessWire)

• Paradromics Launches APEX Partnership Program to Boost Neurotechnology Discovery (Paradromics)

  • Massachusetts General Hospital’s IRB approves initial recruiting for Paradromics’ Connexus BCI clinical study (LinkedIn)

• Neuronoff Demonstrates Multi-Site IPG Compatibility for Injectrode® Platform, Expanding Neuromodulation Beyond Spinal Cord Stimulation (PR Newswire)

• “Resonetics® Completes the Acquisition of Resolution Medical, Expanding End-to-End Integrated Capabilities for Interventional and Neuromodulation Markets” (StockTitan)

• U: The Mind Company Launches Non-Invasive Brain Stimulation Device Requiring No Surgery (EIN Presswire)

• Australis Scientific partners with Innostim Medical to launch wearable device for Overactive Bladder in APAC markets, for distribution with ROHTO (LinkedIn)

• Alto Neuroscience reported full-year 2025 financial results and recent business highlights (Alto)

• ONWARD Medical Schedules Webcast to Report Full-Year 2025 Financial Results and Provide Business Update (ONWARD)

• Neuronetics Appoints Dan Reuvers as Chief Executive Officer (CityBiz)

• PSYONIC & NVIDIA Officially Announce Collaboration at NVIDIA GTC 2026 (Psyonic)

• KeyGrip team at The MetroHealth System complete successful first-in-human implant (LinkedIn)

• Neurofenix’s technology acquired by Bioness Medical, Inc (LinkedIn)

• Sutter Health opens new Brain Health Pathways program at Ray Dolby Brain Health Center (Sutter Health)

• Dr Harry Rowland appointed new Chair of the Board at Kitea Health (LinkedIn)

• ZenoWell Announces Strategic Cooperation with USound to Explore Advanced Sensing Technologies for Next-Generation Wearable Devices (GlobeNewswire)

• Fluent and Araya Inc. Unite to Redefine Neural Speech Decoding for Thought to Text applications (LinkedIn)

• DeepTech Company Zander Labs Enters the U.S. Market With Groundbreaking pBCI Technology (Yahoo)

• Cognitive Signals spins out of Cornell with a diagnostic platform to measure the brain’s responses to natural spoken language (e.g. story telling) with an EEG headset and LLM to interpret signals and identify neural signatures of understanding (LinkedIn)

Regulatory

• Nia Therapeutics wins FDA breakthrough nod for neuromod that treats memory loss (MassDevice)

• LivaNova wins FDA Approval for sleep apnea treatment device (Medical Economics)

• Neurovalens earns European, UK approval for non-invasive neuromod (MassDevice)

• China Clears NEO System by Neuracle, First BCI for Commercial Use (Sixth Tone)

• Letter asks Congress for nearly $500 million to sustain BRAIN Initiative (The Transmitter)

• Opinion: Congress must pass legislation to ensure Medicare covers breakthrough medical technologies (Stat)

• Incorporating Voluntary Patient Preference Information over the Total Product Life Cycle: Guidance for Industry,FDA Staff, and Other Interested Parties (FDA)

• FDA TAP Update: 115 devices enrolled in the program (FDA)

• Data Show Dramatic Slowdown in NIH Grantmaking (AAU)

  

📌Community Board

🆕Pin your news - Highlight key deals, events, roles, or announcements!

• Cambridge Innovation Institute Announces Acquisition of Neurotech Reports (PR Newswire)

• Synaptrix Labs: Join our NYC research study to help develop next generation neural control technology. Get paid $50 for 90 minutes. Multiple sessions allowed! Learn more and sign up here

• Neurotech X & Imperial host the Global Neurohack April 10-12 at Frontier Tower in San Francisco: 3 days, 3 tracks, and 100+ students from a dozen universities. Attend, Sponsor, or Get Involved!

• The 4th Annual California Neurotech Conference at UC Berkeley on April 26 is co-hosted by six University of California student chapters. It seeks to convenes next-gen leaders across academia and industry. Register here.

• iBCI-CC Meeting Save the Date: Oct 16, 2026 - Washington DC (iBCI-CC)

• New Orleans BioInnovation Center’s (NOBIC) global pitch competition applications now open! “We invite neurotech and brain health founders from anywhere to compete for $100k in non-dilutive funding, lab space, and grant writing support.”- Apply today

• GreyMatters Health opens applications for Spring / Summer M&A Associate & Summer Associate

Industry

• Meta Launches TRIBE: An AI Model of the Human Brain: Predicting neural responses to sight, sound and language (Meta)

• From SCAN to SPARK: China’s Galaxy Brain Scientific Enables a New Paradigm in Non-invasive, Personalized Precision Treatment for Parkinson’s Disease (Morningstar)

• Wuhan advances development of brain-computer interface industry (China Optics Valley)

• Comind publishes first papers: Monte Carlo simulations of time-resolved blood flow index (SPIE) and CoMind R1: a time-resolved interferometric optical neuromonitoring system for pulsatile cerebral blood flow measurement at late times-of-flight (SPIE)

• Fareon: Microtesla Magnetic Therapy for cognitive impairment in post-acute sequelae of SARS CoV-2: A randomized controlled feasibility study (MedRxiv)

• Araya launches JapanEEG — an open EEG database for non-invasive speech BCI research: https://japaneeg.araya.org (LinkedIn)

• Nature Translational Psychiatry Study Reveals Distinct Functional Neuronal Signatures in Patient-Derived Brain Organoids with Itay&Beyond’s Neurotech Platform (GlobeNewswire)

• 28bio’s Endurance Study Meets Primary Endpoint, Showing CNS-3D Brain Organoids Predict Clinical Seizure Liability (PR Newswire)

• Sequential Bilateral TMS Protocol Offers Durable Relief for PTSD Patients (Morningstar)

• University of South Carolina opens new Brain Health Center (WACH)

• Beacon Behavioral Partners Welcomes Novus Neurology and SunCoast Psychiatry (GlobeNewswire)

• Staff at New Data Center Powered by Human Brain Cells Need to Swap Out Cerebrospinal Fluid Every Day (Futurism)

• Beijing-backed brain chip firm NeuCyber Neurotech says it is 3 years behind Musk’s Neuralink (Reuters)

• Graymatters: ‘The coolest thing:’ Cutting-edge video game PTSD treatment now offered in Conway (WPDE)

• Naqi Logix Provides Validation by Demonstrating Hands-Free Control of Kinova Robotic Arm Using Neural Earbuds (EIN Presswire)

• Cionic, Insightec, Medtronic, Beacon named in top 10 most innovative med device companies (Fast Company)

• Cognito Therapeutics Presents New Data on Spectris™ in Alzheimer’s Disease at AD/PD™ 2026 (Business Wire)

• NANS 2026: Abbott’s Vision for Neuromodulation (SmartTRAK)

• Palm Health Foundation Convenes Global Brain Health Leaders to Launch Inaugural Brain Coast Advisory Council (SFHN)

• Former Director of U.S. National Institute of Neurological Disorders and Stroke Joins the Invisible Wounds Foundation (Invisible Wounds)

Neurotech.TV

• Neuralink Update — March 2026 (NeuraPod)

• Karen Rommelfanger: Why Neuroethics Matters in the Age of Brain Technology (Dana Foundation)

• How SynchNeuro Is Using Brain Data to Personalize Metabolic Health (Startup Health)

• The TMS Podcast With Steve Harvey and Greg Malzberg (Frontier Psychiatrist)

• They’ve Revived Dead Brains. And Now We Might Finally Get Some Cures (Core Memory)

• Serge Picaud - Director of the Paris Vision Institute (Iconeus Talks)

• How AI Is Hijacking Our Brains with Tim Requarth (Thriving with Addiction)

• His Family Faced Alzheimer’s Too Late. Now He’s Building AI to Change That (Startup Health)

• The Brain Treatment That Helped Get Her Life Back - Derrick Buchanan (TEDxStanford)

• Casey gets his voice back - Braingate trial participant using BCI for daily communication (LinkedIn)

• Translating Voice to Speech: Neuralink’s VOICE trial (LinkedIn)

Society

• Araya launches Trusted Neurotechnology Initiative (TNI), a public interdisciplinary effort exploring how neurotechnology can move from research into everyday use in ways that remain responsible and trustworthy (Araya on X | https://trustedneurotechnology.org )

• Promise and peril: Neurotech between wellness and medicine part two (CfG)

• Meet the Man Making Music With His Brain Implant (Wired)

• Financial Decline Accelerates Brain Aging (Neuroscience News)

• Your Neighbor’s Brain is Your Business (Jordan Shlain)

• Tango Therapy: How the Dance of Passion Is Helping Parkinson’s Patients (NYTimes)

• Introducing “Neurotech between wellness and medicine”(CFG)

• The data gap that costs women their cognitive health (FastCompany)

• In the race for a brain economy, developing countries have chance to win (DevEx)

• I wore Meta’s smartglasses for a month – and it left me feeling like a creep (Guardian)

• Head injury survivors help us understand the brain (NHS)

• Art of Parkinson’s: A virtual gallery of original artwork and stories from people with Parkinson’s, sharing how they’ve reclaimed parts of themselves with DBS therapy (Abbott)

  

Research

• BD² Integrated Network Data Release: Largest multi‑modal psychiatric dataset now available to accelerate breakthroughs in bipolar disorder (BD2)

• Wearable optomyography enables continuous neuroprosthetic control (Nature Scientific Reports)

• A right-hemispheric language network at single-neuron resolution (BioRxiv)

• Towards Magnanimous AGI: A neuroscience-first strategy for aligning advanced AI and the teams executing it (Amaranth Foundation)

• Wearable intelligent throat enables natural speech in stroke patients with dysarthria (Nature Communications)

• Active dissociation of intracortical spiking and high gamma activity (Nature | Northwestern)

• Feinstein Institutes research finds early brain warning signs in severe liver damage (Northwell)

• Computational framework to predict and shape human–machine interactions in closed-loop, co-adaptive neural interfaces (Nature Machine Intelligence)

• New Soldier-Worn Tech Tracks Brain Activity During Blasts to Flag Potential Trauma (NextGenDefense)

• Stanford Scientists Just Discovered a Remote Control for the Brain That Could Reverse Memory Loss (Inc)

• Meet the 2026 Brains Fellows! (SpecTech)

• Can Electrical Stimulation Restore Sight?Electrode arrays could help regenerate damaged optic nerves (IEEE)

• New Collection: Multi-Organ Wearable Bioelectronics for Neurological and Autonomic Health (Journal of Bioelectronic Medicine)

  • “We seek papers on ear-EEG and novel cranial sensing form factors, non-invasive vagal and autonomic monitoring, flexible electrode arrays for gastrointestinal and cardiac sensing, closed-loop wearable systems, and data-driven approaches for integrating multi-organ physiological signals into actionable clinical insights.”

• Nature Announces Nature Progress Brain Health, a selective open-access journal within the Nature Portfolio (Nature)

That’s a wrap! What did we miss? Let me know for next time.
Did you know you can unlock free membership by referring your friends and colleagues to Neurotech Futures?

Representations is a new limited series exploring neurotech’s evolving business frontier. This is produced in partnership with PL Neuro, a project by Protocol Labs. PL Neuro accelerates neurotechnology and neuro AI through field building, strategic investment, and scientific research. Their worldview is deeply technical at every level, yet wholly focused on enabling futures of human flourishing and empowerment. Over the coming months we’ll explore key topics, trends, and themes, featuring experts from PL Neuro’s ecosystem and market insights curated from Neurotech Futures’ platform.

Business Model Innovation In the AI Era

If BCI companies are also data companies, and data companies are AI companies, are BCI companies becoming AI companies?

This evolving trajectory suggests unprecedented opportunities for social and economic impact far beyond the traditional bounds of the medtech industry.

At the core of this transformation is a powerful bidirectional synergy: neural foundation models - large AI systems trained on human brain activity - unlock new BCI capabilities, while proprietary BCI data drives the performance of those models. While this intersection is classified as “NeuroAI,” the real story is the wave of business model innovation being unleashed before our eyes.

“The term NeuroAI has no single definition,” wrote Anthony Zador from Cold Spring Harbor, “but it has largely come to refer to two related and partly intertwined research programs…neuroscience inspiring advances in AI, and AI providing a testing ground for models in neuroscience,” describing a positive feedback loop accelerating progress in both fields.. The NIH summarizes NeuroAI as “a framework where neuroscience and AI drive reciprocal advances with mutual benefits.”

These benefits range from publications and large scale datasets to new methods and applications, private IP, revenue and more. Where, when, how, and to whom will such benefits accrue? On the flipside: What is brain data worth? Who is willing to pay? What does it cost to access?

Your mileage may vary across a global landscape of independent research labs, non-profits, academic institutions, public-private partnerships, established companies, and startups, including but not limited to today’s leading BCI companies.

To me, NeuroAI offers a keyhole view into business model innovations that will drive neurotech’s scalability beyond medical device markets. It’s already begun. Dileep George calls it “closing the loop between AI and neuroscience.” A precambrian explosion of new models, brain mapping platforms, and neurobiology-inspired applications is afoot. It’s only 2026 and current active markets already encompass product R&D, data licensing, and other applications.

The exponential growth of high resolution neural data and ever-shrinking application development lifecycles are creating a glidepath for BCI to move from niche medical devices towards deeptech platforms and beyond. NeuroAI companies are emerging, built on an ML-tapestry of datasets to answer the question: What are we using this data for?

Introducing PL Neuro

ICYMI: Neural Data On the Move

Today, a BCI startup’s intentions for the creation of novel data-generating interfaces, development of proprietary models and other IP using this data, and negotiation of commercial contracts on the basis of those assets…is just business, right?

Sort of. Traditionally, data strategy in BCI mostly stayed between FDA-painted lines, prioritizing well-established processes across product development, animal studies, and the gauntlet of regulatory submissions through clinical and pre-commercial evidence generation stages.

But 2025 was a tipping point, with key signals emerging that BCI companies are neural data companies. In this new paradigm, BCI companies act as the ultimate gatekeepers for neural data, translating exclusive access into immense strategic and commercial value.

• Synchron + NVIDIA = Chiral: A year ago Synchron announced a foundation model to enable self-learning, personalization, and more. This month’s Wired story highlights the acceleration at play for Synchron’s clinical trial participant Rodney Gorham. Mr. Gorham went from a single click BCI user five years ago to “using two iPads side by side, switching between playing a game on one and listening to music on the other.” Is the Stentrode an endovascular implant, or the key to a bespoke NeuroAI system for tunes, chill, dim, nom, vroomba and whatever else Mr. Gorham wants to try?

• Precision’s 510k & Medtronic Deal: Securing a 510k clearance for 30-day implantations last spring opened the door for Precision Neuroscience to sign a historic partnership with Medtronic this January. In the deal, “Medtronic will also get access to anonymous brain data, which it can use for research, development, regulatory submissions, and product improvements, both for this specific system and for others.” With Medtronic’s sales reps developing the market, Precision has opened a scalable and revenue-positive channel for BCI adoption, a first (but likely not a last) for the field.

• Paradromics Apex Program: Following initiation of their first-in-human implant and FDA safety study, Paradromics just announced a new research platform launching with five leading academic partners to modernize research studies with the company’s high bandwidth Connexus BCI.

• Neuropace: Biobucks & FM: In 2025, Neuropace hit $100m in revenue for the first time, driven by sales of their implanted RNS system. But it was the tail end payments of a modest $5m, two year biobucks deal with Rapport Therapeutics that pushed Q3 and Q4 adjusted EBDITA into the black for the first time since their 2021 IPO. Now they’re adding “a pipeline of more data deals” to grow profitability, while hiring more nurse navigators and advancing an in-house foundation model towards a closed loop system to better serve their patients.

Gradually, Then Suddenly: Growth of Neural Data

In addition to a rise in the total count of people living with BCI, DBS, or other neural implants worldwide, key technology and business trends will further compound the growth of neural data in the coming decade.

• Self-Improving Therapeutics - Motif Therapeutics’ Founder and CEO Jacob Robinson sees therapeutic BCI for mental health evolving on a similar growth arc as solar panels, LEDs, and computers. Charting side-by-side growth of microprocessor transistor count and clinical trials for psychiatric brain stimulation, he describes the latter’s “doubling time of 4.7 years.” But neurotech must become more than just medical devices to reach exponential adoption. AI-native BCI companies will leapfrog the “legacy architectures” designed along narrow regulatory and clinical corridors. The emerging era of improvement-native neurotech should auto-upgrade like the OS on a phone or laptop, driving advances and discovery of new features proactively, in user-informed loops.

• Evolution of Interfaces: Five years ago, Dr. Edward Chang wrote about the limits of commercially available BCI tools: “Many of these applications suffer in performance and utility in humans because of the large electrode sizes and low electrode density in FDA-cleared, commercial-off-the-shelf (COTS) electrode arrays.” But that was then, this is now: Chang founded Echo Neurotechnologies two years ago to advance a state of the art BCI system consisting of higher bandwidth arrays, reversible implantation, and fully wireless capabilities, focused on speech restoration and beyond. With new arrays emerging, industry standards for electrode and channel count five years from now feels unimaginable.

• New Economics & Economies: Science Corp has paved a business onramp for such startups building novel interfaces to accelerate through clinical studies at a fraction of the hundreds of millions of dollars it normally costs. “Our imperative is to become the first BCI company to scale and achieve profitability,” says chief strategy officer Darius Shahida. “I think that BCI is not a specific product,” noted founder & CEO Max Hodak. “I think there’s going to be a bunch of BCI companies going after different applications where different types of probes will make sense. To me, it firmly feels like we’re in the takeoff era.”

• Towards Ultra Futures: Merge Labs is in the early days of combining ultrasound and gene editing to create higher resolution neuroimaging than is currently possible with physical electrode arrays. “One of our core beliefs,” co-founder Mikhail Shapiro told Ashlee Vance, “is that we can build BCI that can interface with many more neurons in the brain than is possible with existing technologies in a form factor that is much less invasive than existing technologies.”

Governance: Gates or Guardrails?

The intended and unintended practices around neural data strategy are of growing global interest from beyond the industry. Last November UNESCO adopted a “non-legally binding” “global legal framework” for ethical development and use of neurotechnology. The World Economic Forum has issued a call for self-governance, calling for “regulation as enabling innovation infrastructure” and advancing a new initiative, the “Neuro Trust Index,” for neurotech developers to align with public interests.

INBRAIN Neuroelectronics CEO Carolina Aguilar’s comments following the company’s AI partnership with Microsoft EMEA show tight self-governance at play: “Neural data generated through an INBRAIN device belongs to the patient, and access is tightly regulated under clinical trial protocols, institutional review board oversight, and all applicable privacy laws. INBRAIN does not commercialize patient data, and Microsoft does not access, store, or own patient-identifiable neural information.”

Protecting patient identity and maintaining regulatory compliance are best practices for any medical device company, but developing advanced “human in the loop” applications into individuals’ preferences and personal digital ecosystems goes beyond healthcare. As for the legion of startups building emerging consumer applications from the growing terabytes of EEG, EMG, speech, image, video, and multimodal data: In the US, a growing patchwork of regulations are now targeting the recording, storage, sharing, and downstream applications of “neural data” with an eye on protecting consumers from data misuse.

Sophisticated governance is challenging. The feasibility of regulating a broadly defined category of data used by consumer and medical device ecosystems remains to be seen. If such laws are passed, regulators must take care to avoid the unintended consequences of hampering access to innovation for people living with stroke, Alzheimer’s disease, severe depression, spinal cord injury, ALS, and other as-yet-uncurable conditions.

Beyond Health: Emerging Applications

Today, decoding neural data drives functional quality of life improvements for BCI end users in clinical studies, driving medtech product development efforts, opening new inroads to drug discovery.

But of course, implanted BCI companies are not the only ones building at the neuro frontier today. As AI redefines the playing field, what will emerge over the next decade? Neural foundation models are creating massive downstream opportunities that span myriad potential use cases across biology, computing, and beyond.

• Agents to Agency: Dozens of NeuroAI startups are building next-gen wearable-driven platforms to collect, decode, train on, and harness user intentions into a variety of applications, from wheelchair movement, device control, thought to text, and beyond. Meta’s EMG wristband offers a roadmap, training on 10,000 users so that “out of the box, it can work with a new user it has never seen data for,” as per Patrick Kaifosh, co-founder of CTRL Labs and director of research science at Meta’s Reality Labs.

• More Efficient Computing: A recent study showed how an AI built from monkey-derived artificial visual neurons could be re-engineered for far greater efficiency, at comparable performance. The authors offer early speculation about how this could theoretically improve self-driving cars. Bigger questions beyond saving energy are emerging as small computers powered by neural organoids can already play games.

• Connectomes Of Mice & Men: Two years after a fly’s brain was fully mapped across neuronal connections (aka a connectome) in the Flywire project, Eon announced the first integrated attempt at a virtual fly simulation that “predicted behavior with 91% accuracy.” The point is not about valuations of a digital drosophila - it’s about wondering what will be possible in two, five, or 10 years that is impossible today. As E11 Bio works to map a mouse connectome, the human brain is drawing more interest, too.

What’s Next?

As addressable markets expand and emerge into view, the possibilities may be virtually infinite.

The interplay of foundation models and today’s leading BCI are already powering cutting edge clinical advances that have never been possible: decoding speech, movement, vision, emotion, touch, and more. It is easy to forget that until this decade, such applications were hard to believe!

From GUI to mouse and keyboard to smartphones to BCI, interfaces between brains and computers have always been a gateway to novel computing paradigms and transformative social applications. The continued emergence of genre-bending uses, novel form factors, more powerful decoders, expansive business partnerships, and intriguing new players is poised to continue.

So where do we go from here? In a word, forward.

In forthcoming issues we will be diving deeper into the key topics driving advances in this frontier, from creative financing strategies to competing for engineering talent to the growing role of globalization in shaping neurotech’s progress. Stay tuned and hit reply:

• Startup founders building in this lane - share what you’re working on

• Leaders in policy, investing, or ops - I’m eager for your perspectives

• Curious readers - let me know what you want to learn more about!

Disclaimer: This content is provided for informational purposes only. It reflects the views of the author(s) at the time of publication and should not be relied upon as financial, legal, medical, or investment advice. Views are subject to change. Featured projects are highlighted for informational purposes only. Inclusion does not constitute an endorsement, recommendation, or investment advice by the author or by PL Neuro. PL Neuro may hold a financial interest in some or all companies referenced. This material may contain forward-looking statements, including projections, plans, and expectations regarding future events or performance. Such statements are not guarantees, involve known and unknown risks and uncertainties, and are subject to change without notice.

Last November I spoke with Cognito’s CEO Christian Howell and Rockefeller Neuroscience Institute Executive Chair, Dr. Ali Rezai, after the two orgnanizations broke ground on an innovative collaboratory to build a foundation for value-based dementia care models.

I caught up with Howell again to learn more about their new investors and understand the company’s commercial roadmap with this funding secured.

Milestones and Momentum

Howell described three milestones for this funding: “First is the completion of our HOPE pivotal trial. The last participant will come out of HOPE in June. We expect to give a top-line analysis in August.

Second, we’re using this to lean into our regulatory preparation. We’re taking full advantage of our Breakthrough designation, asking our FDA review team questions now.” The company is targeting de novo submission by the end of the year.

“Finally, we’re doing the work for cost-effectiveness and health outcomes research. That’s why the Brain Health Collaboratories are so important—they give us the ecosystems to do this analysis robustly so we can take it forward to CMS, commercial payers, and states.”

Between completing their pivotal study in August and submitting their de novo application in November, Howell shared the company’s upcoming plans for two additional collaboratory partnerships and expand clinical validation to at least two new conditions by May.

“We’ll focus on getting the Alzheimer’s launch right,” Howell said, “while exploring new areas like Parkinson’s, MS, chemo brain, long COVID, Huntington’s, and potentially TBI, stroke, epilepsy, and sleep.”

Related Reading About Cognito Therapeutics

See also CEO Christian Howell’s approach to Positioning with VCs & Category Creation from Neurotech Insider #6 (Dec 2025)

Ripples and Realities for The Field

Big funding is a headwind in neurotech, with five billion dollars of private capital invested last year alone. Yet despite nine-figure financing rounds in neurotech emerging each month, they tend to go to implant-based startups, most recently Science Corp’s Series C of $230 million, or billionaire-backed moonshots like Nudge or CoMind.

Howell described the challenging funding climate over the last 18 months, saying “Investors recoiled into their existing theses. Cognito clearly lives outside of those. We aren’t a traditional biotech, and we aren’t a traditional medtech.”

“We wanted investors who looked at this from the disease out, rather than the modality in,” Howell said. “When we started talking to family offices that had pivoted into institutional investors, we found traction with those who recognized that sensory stimulation can impact brain health.”

Will this financing stimulate broader interest in VC-backed clinical therapeutics using light and sound? One active neurotech investor I spoke with who was not involved with the company said if Cognito’s de novo goes through, that might spawn new fast follow competitors chasing in predicate pathway to a 510(k). But they were more convinced that the company’s progress will help build confidence more broadly in noninvasive neuromodulation plays into diseases of dementia.

Earlier stage academic spinouts like Austria’s Syntropic are advancing clinical work in treatment-resistant depression. Consumer-first companies building photobiomodulation devices to treat mild cognitive impairment, like Clarity, Vielight, or Optoceutics are actively advancing general wellness devices, but face challenges in scalability without a path towards regulated clinical market access.

Sinaptica Therapeutics is on example of a company that could soon command larger funding, but for a different approach. The company was founded in 2021 to target Alzheimer’s disease as an electrical network disorder with transcranial magnetic stimulation (TMS). They are a few steps behind Cognito, getting FDA Breakthrough Device designation in 2022, and publishing phase 2 data last year.

The study met all primary endpoints and suggest the treatment may slow disease progression. In recent years they have forged strategic long-term partnerships with suppliers like Nexstim and clinical systems like Baycrest, a 10,000 patient, 23-site neurology clinic in Canada, that included financing and commercial support.

In the last two years, new pharmaceutical treatments and blood-based diagnostics employing an amyloid-based path to treating Alzheimer’s disease have hit the market. Yet this may further create the need for disease modifying treatment that can be delivered earlier in peoples’ care journeys. Sinaptica’s CEO Ken Mariash has said, “Firms targeting amyloid beta are going after the ‘usual suspect.’ We need to do more than more than just clean up the ashes after the fire.”

Cognito’s methodical clinical progress and commercial acceleration playbook has unlocked investor confidence in a late-stage clinical neurotech effort in Alzheimer’s Disease. If their first mover momentum culminates with a green light from the FDA, and the company secures meaningful reimbursement, they would become the first neurotech effort that offers biotech‑grade evidence. Could that eventually command biotech‑scale returns?

Howell is optimistic. He shared how this recent fundraising effort has helped them refine their value proposition, in Alzheimer’s and beyond: “This is a poly-pathologic disease that needs a multi-mechanistic approach. Single targets aren’t going to win, not just for Alzheimer’s disease therapy. We believe this will define a new class of disease modifying therapies that can be enormously impactful to a much broader group of patients and families.”

Originally published in Forbes Mar 06 2026

Neurotechnology’s march continues boundlessly despite growing tumult around the world. Be it a refuge for capital, cognition, optimism, or deeper human impulses in an uncertain era, the field is taking on new significance across market segments and investment timelines, year over year and month over month. Let’s dive in to notable activity from the first half of March:

• Over $400m in new funding, with large series C rounds to Science Corp and Cognito, as well as deals in sleep, implanted pain, prosthetics, BCI, and EEG.

• A new FDA clearance and new study results in TMS, other published data from clinical studies in implanted sacral nerve stim, non-invasive VNS, and digital therapeutics, plus new agency guidance on weight loss treatment.

• Paradromics’ first-in-human BCI implant. Real world studies of Kneu’s Parkinson’s wearable. Patient preferences for Setpoint’s arthritis impantable. New EEG applications in ADHD and sleep.

• “And More” - A neurotech OG rebrands. Solid Reports. News from inside China’s BCI race. Organoids in mini-computers & data centers. SimFly, Brainfry. And in one handwavey acquisition, one ring to rule them all…

26 months has brought us to 50 editions! Thanks to our ecosystem partners, collaborators, members, and readers like you for making it possible. Here’s to the next 50…

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• Check out upcoming conferences and time-sensitive opportunities from friends of the platform in the Community Board below.

👋🏽 Hi, I’m Naveen. I believe brain health is human health. You are one of the 4,047 readers of my biweekly reports on emerging neurotech markets.
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• Resonant Link Medical: Preserve capital and derisk development while making your device smaller, smarter and longer lasting. Book time with Resonant Link Medical — or reach out at LSI — to find out how

• NANS: NANS Joins Multi-Society Comments on Proposed BVN Coverage Policy - Read More

• TTP: The role of algorithms in closed-loop neuromodulation - How hardware limits shape algorithm performance, and what makes closed-loop systems work beyond the lab -` Read the full insight

• Datwyler: Recent work from EssilorLuxottica and Politecnico di Milano demonstrating Softpulse® dry electrodes integrated into smart glasses for EEG/EOG sensing and key challenges for scalable consumer devices - Read more

• BrainMind: Explore BrainMind’s Alzheimer’s Prevention Pyramid: a landscape of over 50 concrete actions you can take to support a healthy brain as we age

Funding

• Science raises $230M Series C to Advance Brain-Computer Interface Technology at a $1.5B valuation (Business Wire)

  • See Neurotech.TV for insights into the company’s path forward

• Cognito Therapeutics Announces Oversubscribed $105m Series C Financing to Advance Spectris™ in Alzheimer’s Disease (BusinessWire)

  • My Forbes article about this deal will hit your inbox mid week.

• Eight Sleep Raises $50M at $1.5B Valuation To Expand Into ‘Predictive, AI-Driven Health’ (Crunchbase News)

  • “Tether Investments led the “strategic” investment in the New York-based startup, which has now raised more than $250 million in total funding.”

• ANUEVO Secures $22M Series C Funding to Strengthen ExaStim Regulatory Readiness and Global Operating Scale (ANUEVO)

• Gestala secures CN¥150 million ($21 million USD) Angel Round, the Largest Angel Round in China’s Brain-Computer Interface Sector (Linkedin)

• Egra raises $5.5M to build EEG foundation models (LinkedIn)

• Blue Arbor Technologies raises $5 million from Ottobock, announces first-in-human implant of its RESTORE External Sensing Unit (Medical Design and Outsourcing)

• Nubrain raises $565K to make thought a native input to AI (Linkedin)

• Breakout Ventures announces their $114 Breakout Ventures Fund III (Linkedin)

Commercial

• Microtransponder announces corporate name change to Mobia Medical (Globe Newswire)

• OURA Acquires Doublepoint to Expand AI-Driven Interaction Capabilities (Oura Ring | Bloomberg)

• Natus expands availability to expert-level review of EEG with global launch of autoSCORE AI analysis tool (PR Newswire)

Regulatory

• Soterix Medical Announces Clearance of SPRY Transcranial Magnetic Stimulation (TMS) Therapy for the treatment of Major Depression (PR Newswire)

• Spark Biomedical Launches Pivotal Phase II LUNA Trial for Heavy Menstrual Bleeding (Yahoo Finance)

• Neuspera Medical Announces 12-Month Pivotal Trial Results for the Company’s Integrated Sacral Neuromodulation System for Urinary Urge Incontinence (PR Newswire)

• Click Therapeutics announces that the FDA has published De Novo Summary for CT-132 (Linkedin)

• FDA grants breakthrough device designation to ReVision Implant visual cortex prosthesis (Med-Tech Insights)

• FDA Push for 10-Hour Fake Brain Surgery Trial Raises Ethical Concerns (Bloomberg)

• Medical Devices with Indications Associated with Weight Loss - Premarket Considerations (FDA)

Community Board

🆕Post an ad - Highlight key news, events, roles, or opportunities to connect!

• OctaneOC: Octane’s Neurotech Forum announced for March 26-27, 2026. Let me know if you are an investor or startup interested in attending!

• BADASS Labs: The Nonprofit Advantage: How BADASS Labs Flips Biotech Success Rates to 95% - Read More & Inquire Today

• Cleveland NeuroDesign - 2026 Entrepreneurs Workshop Munich - Application Deadline April 13, 2026 - Apply online here

• ARIA - Last Chance to Submit Interest to ARIA’s Funding Call! See here for details.

Industry

• Paradromics completes its first human implant (MSN)

• Setpoint: Patient Preferences for Treatments of Rheumatoid Arthritis: A Discrete Choice Experiment Evaluating Preference for Novel Neuroimmune Modulation Devices (Journal of Patient Experience)

• Radial Announces Publication of Landmark Study of Accelerated Deep TMS for Depression (PR Newswire)

• Kneu Health Validates Precision Neurology Platform for Cedars-Sinai Clinical Deployment (PR Newswire)

• Fly: Embodiment of whole brain emulation (X)

• Firefly Announces Discovery of New Brain Wave Biomarkers For Differential Diagnosis of ADHD (Yahoo)

• Q&A: Probing electrical signals to understand Alzheimer’s disease (Brain Resilience)

• Human Brain Cells Run New Data Centers in Singapore, Melbourne (Bloomberg)

• China could see widespread use of brain-computer tech in 3-5 years, expert says (Reuters)

• Myelin-Z: PrivateBoost: Privacy-Preserving Federated Gradient Boosting for Cross-Device Medical Data (MedRxiv)

• Q&A with David Sussillo (Neuron)

  • “My advice is don’t try to hide where you came from or pretend to be someone you’re not, but don’t let your background become your entire identity.”

• Landmark Data Validate BrainWay’s SWIFT Deep TMS, Beginning a New Era in Depression Treatment (Brainsway)

• Syntropic Medical completes Phase IIa LUX study of HAVEN, an investigational, non-invasive light-based approach for depression (Syntropic Medical)

• Mirus Medical Device Sector - Market Research Report - (Merger)

• 3 lessons learned from developing a novel neurotechnology device (Medical Design and Outsourcing)

• Invasive BMI Symposium at Osaka University (Linkedin | Med.Osaka)

• Toward accessible, real-time brain decoding: Introducing ENIGMA (Alljoined)

• Three Perspectives on Personalizing TMS Targets (The Frontier Psychiatrists)

📺Neurotech.TV

• The Future of Brain-Computer Interfaces (Youtube)

• Altoida at the Intersection | Episode 1 (Youtube)

• Kevin Sheth: Innovation Toward a Healthier Brain (Yale Insights)

• Dream Engineering, the Proton Radius Puzzle, and an ALS Breakthrough (Youtube)

Society

• AI Use at Work is Causing “Brain Fry,” Researchers Find, Especially Among High Performers (Futurism)

• ‘We’ve Dug Ourselves Into This Hole’: What It Takes for Autism Providers to Succeed in a Challenging Market (Behavioral Health Business)

• What It’s Like to Have a Brain Implant for 5 Years (Wired)

• “You Read My Mind”: Neural Data and the New Wave of Biometric Privacy Protections (JDSUPRA)

Research

• Advancing Brain Stimulation to First-Line Psychiatric Therapy: Wearable Disposable Electrotherapy (Psychiatry Online)

• Restoring brain-to-text communication in a person with dystharia from pontine stroke using an intracortical brain-computer interface (mdRxiv)

• Listening to a consonant chord progression during live face-to-face gaze enhances neural activity in social systems (JNeuroSci)

• Form Factor meets function: anatomy-dependent electrode-skin coupling and signal content in consumer eyewear EEG systems (Linkedin | IopScience)

• Transcranial focused ultrasound induces source localizable cortical activation in resting state humans when applied concurrently with transcranial electric stimulation (Nature)

• New stimulation method builds on focused ultrasound research (Carnegie Mellon University Engineering)

• Accelerated TMS with the H1-coil for depression: A multisite, randomized non-inferiortity trial (Science Direct)

• Scientists make a pocket-sized AI brain with help from monkey neurons (NPR)

• Transcutaneous Auricular Neurostimulation Modulates Pain Perception in Survivors of Stroke With Chronic Upper-Extremity Pain: A Randomized, Sham-Controlled Pilot Study (ScienceDirect)

• Patient-reported outcomes following accelerated vs. standard TMS with the H1 coil for major depression: A multisite randomized trial (Linkedin)

• Yale study challenges notion that aging means decline, finds many older adults improve over time (Eurekalert)

• A Review of Vagus Nerve Stimulation for Disease: Comprehensive Theory and Evidence for Mechanisms of Action (Wiley)

That’s a wrap! What did we miss? Let me know for next time.
Did you know you can unlock free membership by referring your friends and colleagues to Neurotech Futures?

Welcome back to Signals, a members-only newsletter analyzing key commercial developments across the neurotech industry each month.

• Science’s Neurosoft Partnership Offers a New Model for Building BCI

• Apple’s Q.ai Acquisition Brings Neuro-Adjacent Sensing Closer to Consumer Devices

• Brainlab and Precision NeuroMed Partner to Operationalize Brain Access

• The Biological Computing Company Raises Seed for a Commercial Neural Computing Platform

• ARIA Doubles Down on Neurotech, Adding a £50m Scalability Push to Its £69m Precision Programme

• Kintsugi’s Shutdown & Open-Source Decision offers lessons, questions

• TMS Headwinds: Salma’s $80m Series A for CA brain health clinic and Cigna’s TMS Prior Auth decision suggest change is afoot

A reminder: You can unlock free membership to access this analysis, and all of our other articles and archived material. Now, let’s dive in.

Read more

The first step of the application is a 3-page Concept Paper due March 17th.

I spoke briefly with Jacques Carolan, Programme Director for Scalable Neural Interfaces at ARIA, to learn more about this new initiative and their broader strategy in catalyzing neurotech innovation over the last two years. What follows is a condensed interview, with some additional q&a for paying members.

Hi Jacques. Congrats on the new programme call. Who is eligible and how can they apply?

Jacques: We are currently accepting concept papers, which are essentially three-page abstracts, and the deadline for that is March 17th. My team and I will review those and either encourage or discourage people from submitting a full application, though anyone can still submit one regardless. Shortly after that, full applications will open, and we’ll do our final reviews.

As for who we’re looking for, there are two broad categories. We definitely want neurotechnologists who are currently building ways to interface with the brain. However, I want this to be understood as broadly as possible. If you look at the pacemaker, its massive scale was driven by the invention of the transistor. So, what new advances could enable a massively scaled approach today?

I think we’ll see huge advances in bioengineering—engineering cells to traverse the periphery, engineering AAVs, or finding new ways to access the brain through the vasculature or CSF. We want people in the engineered biology and hardware spaces who might not traditionally consider themselves neurotechnologists to bring novel solutions to this problem.

This is a £50 million program. Is that the global budget for these grants? What size prizes do you typically award?

Jacques: The entire program is £50 million, which will be deployed over five years. We’ll have an initial three-year test phase, and then we’ll down-select and double down on the most promising projects for the final two years. For the first phase, we’re estimating a budget of around £2 million to £4 million per project team.

What does “massively scalable neurotechnologies” mean to you, beyond just reaching more people?

Jacques: When I think about ARIA, I ask where we can best address problems. There are many systemic challenges to getting technologies out—like regulation or policy—but ARIA is built to develop technologies and capabilities. I see two main axes for getting tech into the world. The first is efficacy. Some technologies, like hip and knee surgeries, have a high burden to administer but are highly efficacious, so they succeed. On the other axis, we have the burden of deployment. Technologies like SSRIs are relatively easy to prescribe and deploy, even with mixed efficacy.

Our first program focuses heavily on efficacy, asking if we can build better, more personalized circuit-level interventions for brain disorders. This new program, however, targets the scalability side. The vision is to figure out if we can avoid the transcranial procedures that are typically required for advanced neurotechnologies—whether that’s brain-computer interfaces, deep brain stimulators, or even cell and gene therapies.

ARIA

Massively Scalable Neurotechnologies: A possible ARIA programme

What if treating severe depression was as simple as a flu jab? A single injection that precisely and actively tunes your brain's mood circuits for months at a time…

Read more

10 months ago · 29 likes · 3 comments · ARIA

What have you learned from the first program cohort* and from your groundbreaking work building this operation over the last two years?

Jacques: The past two years have taught me that there are so many entrepreneurial people—in the broadest sense—who want to solve incredibly hard, important problems. They don’t necessarily want to go into traditional academia or established industry; they want to build their own things and spin them out. What ARIA does is activate that talent and point it toward a critical white space. We give people the permission to dream big.

We’re even seeing momentum from folks we aren’t able to fund, which shows we’re capturing a really unique time in the space. The technology is changing so fast, and with all the momentum in BCI companies right now, it’s clear to me that the delivery challenge is going to be the main bottleneck to deploying these solutions and helping people at scale.

* Spanning areas of 1) Non-invasive Interfaces, 2) Remote Interfaces, 3) Biological Interfaces, and 4) Future Adoption, with 4, 5, 4, and 6 teams selected for awards, respectively. See the programme page for more detail.

In addition to your programme calls, please tell us about the broader ecosystem initiatives that ARIA supports.

Jacques: A major focus for us is translation—how do we actually get these technologies into the world? We need a talent pipeline for the next generation of neurotechnologists. To that end, we partnered with the University of Cambridge to set up Cambridge NeuroWorks, which is essentially a neurotech accelerator that is based in the UK but open to international applicants.

We’re also tackling the regulatory piece. We’ve partnered with the University of Newcastle and the UK regulator, the MHRA, to second people into the MHRA specifically to work on neurotechnology regulation and develop UK guidance. These initiatives might not seem directly related to technology development, but they act as massive levers for the broader field.

• Cambridge NeuroWorks: The new £multi-million UK-based neurotech accelerator/fellowship program created in partnership with ARIA and the University of Cambridge. Cambridge NeuroWorks Website

• Regulatory Innovation (MHRA): Newcastle University and ARIA’s partnership with the UK’s MHRA to pioneer comprehensive guidance for neurotechnology regulation. Newcastle University Announcement

Additional Links and Resources

• Massively Scalable Neurotechnologies (Programme Overview): ARIA Official Page, Call for Proposals guide

• Concept Paper Submission (TA1): Due March 17th. Application Details via Innovate UK

• Precision Neurotechnologies (The First Programme): ARIA Official Page

• Subscribe to the ARIA Substack to get their latest!

  ARIA

  ARIA is a UK R&D funding agency built to unlock scientific and technological breakthroughs that benefit everyone. By subscribing, you consent to ARIA contacting you. Read more: https://www.aria.org.uk/privacy-policy/

Members can read on to gain additional insight into ARIA’s selection criteria, Jacques’ outlook on de-risking, investing, and neurotechnology futures.

Read more

Case of the Mondays? Here are a few dozen new tabs of notable neurotech news and views to start off your week right.

• $350 million in new funding for brain health, from Salma’s health clinics to medical implants by Envoy, Pharaoh, and Inspire, as well as wearables, neuroimaging, and more grant awards.

• In commercial news, Science Corp’s partnership with Neurosoft leads a slate of important market activity spanning neurosurgical platforms, mental health clinics, and new appointments at startups, nonprofits, and VC. On the flipside, Kintsugi’s shutdown and conversion to open-source is a signal not to ignore.

• New ARPA-H program targets critical care immune system innovation. New ARIA program deadline coming up soon! Startups announce clinical advances in stroke care, tinnitus, pain, depression, and cognitive health.

• Sharena Rice launches a new standards initiative worth a closer look. New Prizes available for researchers around the world. Don’t forget about the company-funded grants in last issue. And if you’re wondering what comes after BCI, scroll down for a Canine-Computer Interface (CCI.)

There’s lots more as usual, too but it’s a busy time so we’ll keep it moving: Scroll down for fresh reporting, commentary, conversations, and some of that elusive “thought leadership” too. On that note: Stay tuned for updates and plenty of fresh content from Neurotech Futures in the coming weeks!

👋🏽 Hi, I’m Naveen. I believe brain health is human health. You are one of the 4,015 readers of my biweekly reports on emerging neurotech markets.
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• Resonant Link Medical: Preserve capital and derisk development while making your device smaller, smarter and longer lasting. Book time with Resonant Link Medical — or reach out at LSI — to find out how.

• NANS: Share your expertise across key neuromodulation areas—including basic science, neural engineering, and clinical innovation—by submitting a session proposal for NANS 2027 Annual Meeting; proposals due March 10th.

• TTP: Rethinking Regulatory Compliance - For Class III wearables and implantables, compliance can either slow you down, or become the discipline that keeps development moving fast and credibly. Read the full insight

• Datwyler: Datwyler’s SoftPulse® electrodes are powering the OpenEarable ExG platform to bring clinical-grade sleep tracking out of the lab and into the real world. Learn more on OpenEarable ExG and the PASCEI project.

• BrainMind: Explore BrainMind’s Alzheimer’s Prevention Pyramid: a landscape of over 50 concrete actions you can take to support a healthy brain as we age: https://brainmind.org/alzheimers-prevention-pyramid

Funding

• Salma Health: $80 Million Series A Raised To Launch Integrated Brain Health Centers Of Excellence. (Pulse 2.0 | Salma Health | Blog Post)

• Envoy Medical Announces Pricing of Up to $78.0 Million Upsized Public Offering (Yahoo Finance)

• Neurent Medical Raises €62.5 million in Oversubscribed Series C Financing to Accelerate NEUROMARK® Commercial Expansion to treat Chronic Rhinitis (Neuromark)

  • Related: Impedance-Controlled Multipoint Radiofrequency Ablation for Chronic Rhinitis: A Randomized Controlled Trial (IFAR)

• Temple raises $54M at a $190M post-money valuation, backed by Steadview Capital, Peak XV Partners, and Info Edge Ventures (Linkedin | Fortune India)

• ProSomnus secures $38M to advance oral sleep apnea treatments (Medical Device)

  • Related: Obstructive sleep apnoea costs UK and US economies £137bn a year, research finds (Guardian)

• Pharaoh Neuro raises $20M, names former Medtronic exec as CEO (MassDevice | Amara Reitmeier)

• Enspire DBS Therapy Announces $10.3 Million Series B1 Financing to Advance Pivotal Development of DBS-Enabled Stroke Rehabilitation (PR Newswire)

• Clee Medical secures Seed Financing to advance Real-Time Brain Imaging for Neurosurgery (Founders Today)

• BrainCheck Raises $13 Million to Expand AI-Enabled Cognitive Care Platform (Yahoo Finance)

• UT Southwestern and UTMB Awarded $500,000 TRC4 Grant to Study Non-Invasive Neurostimulation for Chronic Subdural Hematomas (Globe Newswire)

• CABHI awards $2.6M to 26 startups help healthcare organizations adopt innovative brain health solutions (CABHI)

  • “As part of the program, CABHI facilitated a match between each participating organization and an innovative solution specifically designed to address a challenge that is negatively impacting that organization’s ability to provide quality care to older persons.”

• Science & PINS Prize for Neuromodulation (Science)

• NERVE Program Application (Ontario Brain Institute)

Commercial

• Science, Neurosoft partner on BCI tech (Mass Device | Linkedin)

  • The AWS of Brain Implants (Neurotech Digest)

• Lifeward’s ReWalk Personal Exoskeleton Now Covered by Aetna, Coverage Expands to Include Three of the Largest MA Insurers (Lifeward)

• Health Systems and Strategic Partners Unite to Address Widening Healthcare Gaps in Rural and Underserved Communities (NSCAC)

• Dileep George joins Astera to lead its neuro-inspired AGI effort (Astera Institute)

• Global Collaboration to Advance AI-Driven Discovery for Alzheimer’s Prevention Announced (EIN Presswire)

• Amber Therapeutics strengthens its Board and Leadership team, opens UK headquarters and expands EU feasibility study for mixed urinary incontinence, increasing momentum towards a pivotal trial in the US (First Word Pharma)

• Magnus Medical Moves to Protect Intellectual Property Behind Breakthrough SAINT Accelerated Depression Therapy (Morning Star)

• Stella Mental Health Expands Boston-Area Services with New Newton Clinic as Chief Psychiatric Officer Dr. Brian Boyle Selected 2026 National SPRAVATO Bureau Speaker (PR Newswire)

• X3 Holdings Expands Into AI Healthcare Through Strategic Smartwatch Partnership (PR Newswire)

• Walter Koroshetz Joins the Dana Foundation as a Senior Advisor (PR Newswire)

• CSD acquisition Advances Access to Breakthrough Autism and Behavioral Care in the Southwest US (PR Newswire)

• CraniUS Therapeutics Appoints J&J Senior Executive, Oray Boston Jr. to Board of Directors (PR Newswire)

• Sam Hosovsky joins Jumpspace Ventures as Venture Partner, “focusing on early stage companies emulating the brain, mainly in Japan and China.”

• Precision NeuroMed announces strategic partnership with BrainLab to develop AI-enabled treatment planning platform for Convection Enhanced Delivery (CED) to the brain (Linkedin | Precision Neuromed)

  • “Under the Joint Development and Commercialization Agreement, Brainlab and PNM will collaborate in the development of the CED treatment planning software. As part of the collaboration, Brainlab has been granted an equity interest in PNM, reflecting a shared commitment to the long-term development and adoption of this technology.”

• Why clinical AI startup Kintsugi shut down (Endpoints), makes “$30m Gift to Mental Health Community” by open-sourcing work.

Regulatory

• ARPA-H launches program to revolutionize critical care and help prevent life-threatening events (ARPA-H)

  • Critical Illness Immunological Reprogramming and Control Point Learning Engine (CIRCLE) program, a leading-edge initiative to better track the body’s immune response during critical illness so care clinicians can personalize treatments and save lives.

  • Register for Proposers Day March 11

• Nexalin Participates in and Commends Recent Congressional Momentum Supporting Deep Brain Neurostimulation Research for Veterans and Neurological Disorders (Nexalin Technology)

• Nexalin Announces Pivotal HALO Clarity Trial to Support Planned De Novo FDA Submission Targeting Multi-Billion-Dollar Insomnia Market (Nexalin Technology)

• A provocative proposal asks the FDA to let some AI devices on the market without review (Stat Health Tech)

• Advocacy News: Bipartisan Support for Focused Ultrasound (Focused Ultrasound Foundation)

Community Board

🆕Post an ad - Highlight key news, events, roles, or opportunities to connect!

• OctaneOC: Octane’s Neurotech Forum announced for March 26-27, 2026. Let me know if you are an investor or startup interested in attending!

• BADASS Labs: The Nonprofit Advantage: How BADASS Labs Flips Biotech Success Rates to 95% - Read More & Inquire Today

• Carter Sciences joins Substack with “The Neurotech Newsletter.” See their newest piece, “Brain–Computer Interfaces in 2026: The Translation Era Is Here (But the Hard Parts Didn’t Go Away)”

Industry

• Neurotechnology Standards and Governance: A Curated Reference for Innovators (Sharena Rice | Linkedin)

• Speech Decoding: Where and How (e184)

• Leader in the Neurotech Spotlight: Andreas Forsland, CEO, Cognition (This is Crux)

• Viewpoint: neurotech deserves an EU research moonshot (Science Business)

• App Helps Cedars-Sinai Improve Parkinson’s Care (Cedars Sinai)

• BCI: What’s standing in the way of pivotal trials, FDA approval (Stat News)

  

• Will We All Become Cyborgs? (2Digital | Linkedin)

• Austin Startup Turns Thought Into Motion for Amputees (CBS Austin)

• Closing the loop on mental health:How high-bandwidth brain-computer interfaces could transform psychiatric treatment (Paradromics)

• Precision’s Brain Storm BCI Hackathon 2026 (Joe Sharron)

• Advanced TMS Protocol Demonstrates Increased Remission Rates in Depression (PR Newswire)

• New Directions Mental Health Expanding Life-Saving Treatment (PR Newswire)

• Neuromod Devices reports positive Lenire tinnitus device data (Mass Device)

• Health Moonshot Update: Sana Health’s Regulatory Breakthrough in Pain Control (Startup Health)

• Kandu trial highlights positive outcomes with IpsiHand BCI system (Mass Device)

• Zyphra Releases ZUNA - BCI Foundation Model Advancing Towards Thought-to-Text (PR Newswire)

• Case Review: Long-term pain implants and weight loss (Dr. John Hagedorn)

• 2025 Advances in Brain Health: Brain Health as Capital for Vascular and Cognitive Resilience (AHA Journals)

• NeuroPerspective has released a Neurogram+ (Linkedin)

• Smelling Alzheimer’s Early and Treating It With Sound (LinkedIn)

• Leader in the Neurotech Spotlight: Tetiana Aleksandranova, Co-Founder, CEO, Subsense (This is Cruxx)

• Horao Neurolabs reveals their new company name (Linkedin)

Neurotech.TV

• Living Human Brain Cells Play DOOM on a CL1 (Youtube)

• A gentle introduction into the human brain (Spotify)

• Is The Brain an Analog Computer? Consciousness as Dynamic Brainwave Organization (Youtube)

• Humans of Neuroscience: Interview with Dr. Elisa Kallioniemi (Youtube)

• Dark Patterns, Deceptive Design, and Neurodata with Dr. Mark Leiser (Neurotech Now Podcast)

Society

• Your Brain, Their Rules: The Growing Patchwork of Neural Data Regulation (Cooley)

• When Research Priorities Move Backward, Communities Pay the Price (RxFoundation)

• Walter Koroshetz Joins the Dana Foundation as Senior Advisor (PR Newswire)

• Viewpoint: neurotechnology deserves an EU research moonshot (Science Business)

• Why the ADHD brain is a perfect pairing for AI (Fast Company)

• Cognitive and Neuropsychiatric Function in Former American Football Players (Jama)

• Introducing new Neuroethics News series by Erica Schug (Linkedin)

• As Brain Organoid Science Grows More Complex, So Do the Questions (UNDARK)

• Reframing the Risks of Deep Brain Stimulation: A Comparison of 2.8 Million Elective Surgeries From the NSQIP Database (Annals of Neurology)

• We’re at neurotechnology’s regulatory frontier – here’s what policymakers need to know (WEF)

• The $3 Billion Brain Health Research Initiative in Texas (MMHPI)

• Israeli defense official: “We are working on using the brain to communicate with drones” (Calcalistech)

• New National Agenda Paves the Way for Improved Parkinson’s Care (Parkinson’s Foundation)

• Final Note, Finally (Experiment) - a functional canine movement ML model for vibrotactile haptic platforms

Research

• Transcranial focused ultrasound stimulation enhances semantic memory by modulating brain morphology, neurochemistry and neural dynamics (Nature)

• Focused ultrasound neuromodulation for psychiatric disorders: a scoping review of clinical applications and current progress (Journal of Neural Transmission)

• A retrospective study to assess clinical outcomes among patients receiving a novel sequential bilateral transcranial magnetic stimulation protocol for depression (TMS Journal)

• Neurophysiological and behavioral effects of oscillatory transcranial direct current stimulation (otDCS) (Journal of Neuroscience Methods)

• Noninvasive brain stimulation combined with evidence-based psychotherapy for psychiatric disorders: A meta-analysis of optimal implementation parameters (medRxiv)

• What’s the age of your brain? Neurotechnology study by Colorado doctor has the answer (CBS News)

• A neural network for modeling human concept formation, understanding and communication (Nature Computational Science)

• CL API: Real-Time Closed-Loop Interactions with Biological Neural Networks (Cornell University)

• Human hippocampal neurogenesis in adulthood, ageing and Alzheimer’s disease (Nature)

• Neurosurgeons Are Really Good at Removing Brain Tumors, and They’re About to Get Even Better (CMU)

• Neural Vision Restoration in Ophthalmology (Annals of BME)

• Abdominal ultrasound activates afferent vagus nerve fibers and induces anti-inflammatory effects (PNAS)

• New Clinical Trial Will Assess Brain Tumor Changes After Blood-Brain Barrier Opening (FUSF)

That’s a wrap! What did I miss? Drop us a note for next time.

As the nationwide cold snap thaws, neurotech is still heating up across the board. Here are notable developments from the last two weeks:

• Neuro x AI: As the public AI discourse evolves amidst historic funding, soaring valuations, and departure of safety leaders from top labs, two new deals harnessing neurobiological and real-world multimodal data bet on new paths forward.

• Business Bets: Apple’s latest acquisition shows Big Tech is keen on face and voice tracking. Snap spins out their AR work. Naqi buys Wisear with an all-stock offer. Divergence partners with Mobio for Stress detection. Openwater & Tiesa partner on mental health research, while Cumulus, Soin, and Cognision announce platform news in life sciences.

• TMS Speeds Up: In a landmark decision, Cigna will remove Prior Authorization, historically a major impediment to access. The timing is critical as accelerated protocols advance, with Magnus announcing their first trial participant treated for post-partum depression, and Ampa partnering with a new clinic.

• New Opportunities: ARIA’s second major neurotech program (er, I mean programme) will launch later this month, along with openings at the Paris Brain Institute and research grants announced by Emotiv and OpenBCI. Meanwhile, OneMind revealed their latest cohort of companies, and Ochsner announced a new neuro clinic

• New Research on Parkinson’s disease suggests an underlying network disorder that results in a “stuck” signal. PD patient & advocate Ben Stecher puts it thus: “We are no longer just chasing dopamine; we are tuning the instrument. We are learning to quiet the hyperconnectivity and restore the natural rhythms of the brain.”

As usual: Scroll down for other commercial news, regulatory coverage, industry buzz, research papers, and more, including recent analysis we’ve published here.

Finally, I’m excited to share that some large new ecosystem partnerships are underway at Neurotech Futures. Stay tuned for new content and events heading your way, upgrade your subscription, and hit reply to partner up!

👋🏽 Hi, I’m Naveen. I believe brain health is human health. You are one of the 3,945 readers of my biweekly reports on emerging neurotech markets.
Operators: Upgrade today to get Signals, Insider, and Perks.
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• Resonant Link Medical: Make your implantable smaller, smarter, and longer lasting with Vivigo™ by Resonant Link Medical. 20-minute wireless charging across a wide range delivers fast, uninterrupted power—without compromise.

• NANS: Share your expertise across key neuromodulation areas—including basic science, neural engineering, and clinical innovation—by submitting a session proposal for NANS 2027 Annual Meeting; proposals due March 10th.

• TTP: Medical device development: getting the balance of compliance right - Think about compliance early when developing implantable or wearable devices, but don’t let it become a burden. What really matters at the start to set up downstream success? Read the full insight.

• Datwyler: With top performance, certified biocompatibility, dry use, custom design and scalable manufacturing, SoftPulse® electrodes are best positioned to support wearables for Health & Medical applications. Join us at the HealthTech Global Summit in Basel March 3-5 to learn more.

Funding

• The Biological Computing Company raises $25M Seed (Primary VC)

• From January: Constellation Systems, Inc raises ~$10M to build foundational models of the human brain (Linkedin)

• Vivatronx’s spinal stimulation device for paralysis bags Rs 1-crore funding (Deccan Herald)

• ARIA Announces newest programme: Massively Scalable Neurotechnologies (ARIA | March 02 Webinar)

• Dr. Brett Youngerman receives NIH UG3-UH3 grant to advance a next-generation neural interface for epilepsy monitoring and brain mapping (Linkedin)

• One Mind Accelerator Announces Fourth Cohort of Startups, Advancing Mental Health Innovation (One Mind | Linkedin)

Commercial

• Apple’s second biggest acquisition ever is Q.ai, AI company that listens to ‘silent speech’ (The Verge)

• Wisear acquired by Naqi Logix Inc. (Linkedin)

  • Thanks to the anonymous sleuth who dug up the SEC filing revealing this was an $11.7m all stock deal.

• Divergence Neuro and Mobio Interactive Announce Strategic Partnership for Real-Time Stress Detection (Divergence)

  • See ‘Research’ below for stress tracking with M&M

• Openwater’s Open-LIFU Device Supports Concierge Mental Health Research with TIESA (EIN Presswire)

• Ampa welcomes Bridge Medical Neurology to the Ampa community as the first neurology clinic partner (Linkedin)

• Cigna Removes TMS Prior Authorization: Exactly What Clinics Should Do Starting March 6, 2026 (Rise)

• Magnus Medical launches pivotal trial in Post-Partum Depression (Morningstar | Linkedin)

• Cumulus Neuroscience Enters Japanese Market to Advance Novel Cognitive Biomarkers with Shionogi & Co., Ltd. (Cumulus | Linkedin)

• Soin Neuroscience and Lilac Biosciences Launch Collaboration to Study RNA Signatures in Pain and Neuromodulation(BioSpace)

• Theranica Announces U.S. Coverage for Nerivio Reaching ~130 Million Lives, Attaining Payers Scale Comparable to Leading Migraine Drugs (PR Newswire)

• CorTec announces Successful Second Human Implantation of Its Brain-Computer Interface (BCI) System (Globe Newswire | Linkedin)

• Cognision Launches Cognision 360: A Unified Platform Transforming Neurobiomarker Acquisition, Processing, and Analysis in CNS Clinical Trials (Linkedin)

• Kneu Health Recruits Exceptional Leadership Team to Scale Neurodegenerative Care Across U.S. Health Systems (PR Newswire)

• Adnan Ashraf joins Motif Neurotech as Senior Embedded Systems Engineer (Motif Neurotech)

• Brent Madigan is new VP of Sales at Sense Neuro Diagnostics (Linkedin)

• 150 Practices Join BrainCheck in 2025 as New Cognitive Care Workflows Scale Nationwide (Yahoo Finance)

• Snap Spins Out AR Specs Into Its Own Subsidiary (Upload)

• Muse Brings Deep Sleep Stimulation Home (Business Wire)

• Boston Scientific announces results for fourth quarter and full year 2025 (PR Newswire)

• T.J. Samson Community Hospital is proud to be the first healthcare provider in the U.S. to offer BrainWatch from Natus (T.J. Regional Health)

• Nexalin Launches Neurocare, an AI-Driven Virtual Clinic Designed to Transform Access for Patients with Alzheimer’s, Mood Disorders, TBI & PTSD Care (Globe Newswire)

• Siemens Healthineers and Mayo Clinic expand strategic collaboration to enhance patient care for Neurology and other areas (Mayo Clinic)

• Kintsugi announces shutdown of its commercial operations (Linkedin)

Regulatory

• Encora Therapeutics Receives FDA 510(k) Clearance for Encora X1™, a Breakthrough Wearable Device for Essential Tremor (BusinessWire)

• Sonorous gains US FDA breakthrough designation to treat pulsatile tinnitus with novel BosSTENT device (Neuro News)

• Canada’s Privacy Commissioner Adds Neural Data to its Interpretation Bulletin on Sensitive Information, Making Canada the First Country to Protect Neural Data on a National Level (Mailchi)

• SCIRP Funding Partially Restored (u2fp) & Hearing Set on Spinal Cord Injury Funding Boost (EIN Presswire)

• AdvaMed names Melissa Torres as new leader for technology and regulatory affairs (Med Tech Drive)

• Town Hall - Use of Real-World Evidence to Support Regulatory Decision-Making for Medical Devices, Final Guidance (FDA)

• Students, faculty mystified as NSF turns back applications for prestigious fellowship program (Stat)

• 27 UNIHTED discusses SBIR/STTR reauthorization efforts (Linkedin)

📍Community Board

🆕Post an ad - Highlight key news, events, roles, or opportunities to connect!

• NeuroBionics: New Jobs! Operations Manager, Program Manager, Strategic Marketing Lead (Upstream), Senior Manufacturing Technician. Follow us on LinkedIn for our latest company updates.

• OctaneOC: Octane’s Neurotech Forum announced for March 26-27, 2026. Let me know if you are an investor or startup interested in attending!

• BADASS Labs: Unlock Your Potential: Why Fearless Founders Choose a Biotech Incubator in the Bay Area - Read More & Inquire Today

• NeuroNYC announces updated directory and public resources (Linkedin)

  ---

Industry

• Ochsner to open first-of-its-kind neuroscience institute by year’s end (WWLTV)

• Early Diagnosis of Mild Cognitive Impairment in Primary Care (Clinical Advisor)

• We Can Now Measure the Sleeping Brain (Neurotech Napkin)

• The Future of Whole Brain Emulation (Substack)

• Connectome publishes manifesto for brain data platform (Connectome)

• Neuspera Medical Announces Milestone Case of Traditional Sacral Neuromodulation (SNM) System Removed and Replaced With the Company’s Integrated SNM System for Urinary Urge Incontinence (PR Newswire)

• WAT Medical’s EmTerm Wearable Device Demonstrates Superior Control of Moderate to Severe Postoperative Nausea and Vomiting in JAMA Surgery-Published Clinical Trial (PR Newswire)

• Graymatters Health Reaches Clinical Milestone of 10,000 Prism PTSD Patient Sessions (PR Newswire)

• Randomized Controlled Trial Demonstrated Positive Outcomes for FDA-Cleared Brain-Computer Interface IpsiHand® System in Chronic Stroke Rehabilitation (PR Newswire)

• Neuromod Prize Case Study: Advancing breakthrough neuromodulation therapies from research lab to market (Luminary Labs)

• Published Study Found Underlying Tumor Improvement with Consistent use of Cala TAPS Therapy in Patients with Essential Tremor (PR Newswire)

• INU Researchers Present Roadmap of Ultra-Thin Crystalline Silicone-Based Therapeutics (PR Newswire)

• AI-powered sensor accurately detects neurological disorders using saliva (Donga Science)

• NextSense debuts brain activity-sensing headphones to improve sleep (MassDevice)

• ANEUVO Recognized with Taiwan’s 22nd National Innovation Award for ExaStim® Neuromodulation Technology (Yahoo)

• Unlocking the Brain-Immune Axis: A New Scientific Framework for Hybrid Drugs (Linkedin | Journals)

• PIEZO channels are opening the study of mechanosensation in unexpected places (The Transmitter)

• IEEE Considers Safety Guidelines for Neurotech Consumer Products (IEEE Spectrum)

• BrainScope: Derivation of an intrinsic brain activity biomarker for the earliest prediction of cognitive decline (Scientific Reports)

• The Future of Health Tracking with Earables (Linkedin)

• Bionic sneakers promise to change human mobility (npr)

• Flying drones with your eyes: the brain scientist developing Israel’s future battlefield tech (Y Net News)

• From Diagnosis to Data: Ben LeNail on the Future of Neurotechnology (Medium)

• February 2026 Neuroscience, Neurotech, and Mental Health Newsletter (Linkedin)

• From Peak Performance to Daily Life: The Next BCI Advantage (Medium)

• The sixth bioelectronic medicine summit: Neurotechnologies for individuals and communities (Springer Nature)

• Brainomix to launch next-generation stroke platform equipped with net water uptake technology (Neuro News)

• OpenBCI announces the launch of the Galea Discovery Program - Applications due Feb 28 (OpenBCI)

• Paris Brain Institute Call for Junior Group Leaders in Artificial Intelligence and Data Science (Paris Brain Institute)

• Call for NeuroDiscovery Grant Proposals (Emotiv)

• NeuroTech Course announces registration is open for the NeuroTech Course Spring 2026 Sprint (Linkedin)

• Inside NeuroOne’s brain electrode technology (Mobi Health News)

• Max Hodak, Kevin Tracey, and Zhen Xu listed in Time’s 100 Most Influential People In Health (Time)

Neurotech.TV

• Seizure Diaries Episode 4 | When Cutting Edge Neuromodulation Meets Compassionate, Team-Based Pediatric Care (Cadence Neuroscience)

• Intent Medical Podcast | Dr. Mark Aloia (Youtube)

• Giving Feeling Back to Lost Limbs | Josh Miller, BIOS (Youtube)

• Vagus Nerve Stimulation and the Immune System (Substack)

• RFK Jr. and others launch new addiction and homelessness initiative (PBS News)

• Dana Foundation announces new NeuroSociety Stories coming soon (Linkedin)

• STEIN Fireside Podcast: Unlocking the Brain: Device Evolution, Sensing, and the Road Ahead (Youtube)

• Neurotechnology for Cognition: Recording and Modulating the Human Brain (Neural Implant Podcast)

Society

• Brown University professor John Donoghue wins Queen Elizabeth Price for Engineering (Brown)

• Oregon primate research center to negotiate with NIH on possible transition to sanctuary (The Transmitter)

• Neuroethics Canada announces a new training opportunity, Ethical Considerations in Neurotech (Linkedin | NTMC)

• The brain economy explained: Why strong brains power strong economies (McKinsey)

• Using voice and speech data in healthcare: a scoping review of the ethical, legal and social implications (Frontiers)

• Betting blind on AI and the scientific mind (The Transmitter)

• Neurotechnology and Cognitive Warfare (OpinioJuris)

• US Air Force bans use of smart glasses among its troops – earphones and other Bluetooth devices also limited to official duties when in uniform (Tom’s Hardware)

• U.S. innovation faces dire future under proposed Bayh-Dore gutting (Federal News Network)

• Trump admin is “destroying medical research,” Senate report finds (Ars Technica)

• When Minds Are Turned Into Data: Governing Emotion Technology and Neurotechnology under EU Law (Cambridge)

Research

• Parkinson’s disease as a somato-cognitive action network disorder (Nature | TMRW Edition)

• Ultrafast nanolasers mimic how the brain imagines unseen parts of the world (EBRAINS)

• Cognitive speed training over weeks may delay the diagnosis of dementia over decades (NIH)

• A Needle-Thin Implant Could Transform How Scientists Study and Treat the Brain (SciTechDaily)

• A generalizable foundation model for analysis of human brain MRI (Nature)

• Brain-computer interfaces in poststroke rehabilitation: a meta-analysis of randomized clinical trials (JNS)

• Chinese scientists develop stretchable electrodes for invasive BCI, breaking key bottleneck (Global Times)

• Ripples precede insight in the right human hippocampus (bioRxiv)

• Powerful Chemotherapy Drug Reaches Brain Tumors in Humans Using Novel Ultrasound Technology (Northwestern Medicine)

• ADHD Symptoms Predict Distinct Creative Problem-Solving Styles and Superior Solving Ability (Drexel)

• A quantitative, multimodal wearable bioelectronic device for comprehensive stress assessment and sub-classification (Nature)

  

• Sound waves offer new way to steer blood pressure, Hopkins study finds (John Hopkins Biomedical Engineering)

• Brain Neuroplasticity Mechanisms in Psychiatric Illnesses and in the Development of Novel Treatments (Linkedin)

• Randomized controlled trial of resistance exercise and brain aging clocks (GeroScience)

That’s a wrap! What did I miss? Send news + tips + suggestions for next time.