Neurotech Notables #46: Dec 16, 2025 - Jan 15, 2026

The Holiday Hangover Double-Notable Edition

Happy Friday Readers!

2026 is upon us, and despite the turbulence around the world, it already looks to be historic year for neurotech.

Here are some updates from the last month. This is usually a biweekly, so given the holiday break and the torrid news cycle through JPM & CES, there’s much ground to cover. Here we go.

• Brain-Computer Interfaces: Precision’s deal with Medtronic and Merge Labs’ official funding & launch top the headlines, along with important developments from China, Michigan, and in between. As we wrote earlier this week, the Signals are becoming clearer that the field is maturing.

• Market Partnerships: Deals big and small, alliances, acquisitions, spinouts, across neuromod, sleep, hardware, software, research and more, suggest industry consolidation in entrenched markets and healthy competition in emerging ones.

• Regulatory Roundup: Eight clearances or approvals across mental health, neurosurgery, bladder, sleep, weight, and consumer use cases, plus numerous breakthrough designations and applications, along with an evolving agency frameworks all combine to suggest it is going to be a busy year ahead in Washington and beyond.

• “And More” - Major commercial leadership updates at startups and big strategics. Promising publications from new companies and established players. An eye-opening sleep study. Foundation models. Virtual and Synthetic brains. Consumer acceleration. The neuroscience of nature.

On the personal front: It was awesome to meet up with so many of you in person at Brainmind’s event and our New Year Party. Shout out to Protocol Labs & Datwyler for sponsoring! and, speaking of collaborations:

New Annual Partners: Welcome Resonant Link Medical and BADASS Labs to our Ecosystem. And welcome back to NANS, TTP, Datwyler, BrainMind for another year of partnership. More info & updates on our Ecosystem page.

Stay tuned for our next event, new formats, analysis, and collaborations.

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Interested in Becoming an Ecosystem Partner? Inquire today.

• Resonant Link Medical: RLM launches Powering The Future Within, a bi-weekly podcast hosted by CEO Omari Bouknight. Listen to top founders, engineers, clinicians, and visionaries explore the pivotal moments, breakthroughs and lessons reshaping human health - Subscribe today

• NANS: Last chance to attend the NANS 2026 Annual Meeting in Las Vegas, January 22–25, where top neuromodulation clinicians, researchers, and industry gather for meaningful science, applied innovation, and real-world clinical discussion.

• TTP: How to detect epileptic seizure biomarkers on the vagus nerve in closed loop neuromodulation - Read More

• Datwyler: Learn how SoftPulse® technology can enhance your products with advanced biosensing capabilities - Connect at an upcoming event

• BrainMind: Apply to join Asilomar for the Brain and Mind 2026, where founders, funders, scientists, end users, and policymakers will co-create practical tools for responsible neurotech. Help shape shared practices for the field’s next chapter: Apply Today!

• BADASS Labs: Why a Biotech Incubator is Your Non-Negotiable Edge for Startup Success in 2025 - Read More & Inquire Today

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Funding

• Merge Labs Raises $252m (Bloomberg)

  • See also Merge Labs’ Blog, OpenAI’s statement, and this piece from Wired last month.

• Chinese startup BrainCo raises $280m for iBCI (Neurofounders)

• Spiro Medical Secures $67 Million Series A Financing to Develop a Neuromodulation System for Asthma (PR Newswire)

• Neurable Raises $35 Million Series A to Accelerate Deployment of Everyday Brain-Computer Interface Technology (Business Wire)

• Insightec Announces Spin-Out of Lotus Neuro to Advance Focused Ultrasound Brain Therapies (InsightTec)

• NeuraWorx Closes Oversubscribed Seed Round Led by Nexus Neurotech to Advance Neurotechnology Therapy for CNS Disorders (Business Wire)

• Neurosom™ announces oversubscribed bridge round financing as company advances towards Seed Round in 1H 2026 (Neurosom)

• CranioSense Awarded $5.5 Million in Federal Grants to Validate Noninvasive Neurotech (PR Newswire)

• AI Stroke raises US$4.6 million seed round to advance pre-CT stroke triage (Neuro News International | Linkedin)

• 2025 HSBC venture healthcare report (HSBC)

• Epilepsy Foundation’s Shark Tank Competition 2026 Announces combined awards and investment of up to $250,000 - LOI due Feb 6 (Epilepsy Foundation)

Commercial

• Precision Neuroscience™ and Medtronic Partner to Integrate Layer 7 Brain–Computer Interface with Medtronic Neurosurgical Platform (Globe Newswire)

  • Wow. While the details of who gets what in this partnership will be slow to emerge, the optics are clear: this is a big move for BCI and for both of these companies. Send me your questions and thoughts.

• Boston Scientific Announces Agreements to Acquire Valencia Technologies Corporation and Penumbra for $14.5B

  • Any informed guesses on size of the Valencia acquisition?

• Ozlo Expands Acquires Segotia (Fitt Insider)

• Surf Therapeutics Announces Early Feasibility Study (EFS) To Advance Non-Invasive Approach to Neuromodulation for Rheumatoid Arthritis (Business Wire)

• Soin Neuroscience and BIOTRONIK Neuro Announce Research Collaboration to Advance Novel Waveforms and Personalized SCS Tuning (Yahoo Finance)

• Rune Labs Taps Tempus Exec as New CEO to Expand AI-Enabled Neurology Care (Business Wire)

  • See also: 2025: A Year in Review (Rune Labs)

• Neurophet Appoints Josh Cohen, Former Executive from a Global Medical AI firm To Accelerate US Market (Neurophet)

• Medtronic’s Global VP of Brain Sciences steps down (LinkedIn)

• Medical AI Expert Wido Menhardt Joins FemPulse Scientific Advisory Board (Globe Newswire)

• Omniscient Secures New CPT® Code for Connectomic Analysis, Validating the Clinical Utility of Brain Network Mapping (Globe Newswire)

• Lungpacer reports first commercial procedures with Aeropace neurostim system (Mass Device)

• From Nov: LivaNova’s VNS Therapy for Drug-Resistant Epilepsy Procedures Receives Increased Provider Reimbursement from U.S. Centers for Medicare & Medicaid Services (Livanova)

• Sinaptica Therapeutics Completes Scientific Advisory Board, Bringing Together Leading Voices Across Patients, Science, Medicine, and Commercial Strategy (Sinaptica Therapeutics | Linkedin)

• Cumulus Neuroscience Appoints Ricardo Sáinz Fuertes, MD as New Board Chair (Cumulus Neuroscience)

• Brooke Harding joins CIONIC as Chief Commercial Officer (LinkedIn)

• Mee Audio launches flagship headphones featuring spatial audio with fast head tracking by IDUN audio (LinkedIn)

• Migraine Buddy announces partnership with Oura (LinkedIn)

• Cortigent files (another) S-1 amendment, announces clinical trials in 2027 (LinkedIn)

• Washington University in St. Louis names Focused Ultrasound Center of Excellence (WashU)

• University of Michigan Health opens BCI clinic, among first in nation (Michigan Medicine)

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PathMaker Neurosystems just announced completion of their ALS EFS and an upcoming presentation at 2026 MDA Clinical & Scientific Conference in March 2026.

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Regulatory & Federal

• Neurolief receives FDA PMA Approval for First At-Home Brain Neuromodulation Therapy for Adults Whose Depression Was Not Adequately Improved by Antidepressants (PR Newswire)

• NAOX Technologies LINK (NX01) receives FDA 510(k) clearance for in-ear EEG designed for use in healthcare and home environments (LinkedIn)

• FDA Clears Empatica’s EmbraceMini for Sleep Monitoring (Empatica)

• Medivis Secures FDA Clearance for Augmented Reality Navigation in Cranial Neurosurgery (G MedTech)

• BlueWind Medical Received FDA 510(k) Clearance for Enhanced Revi Wearable Supporting Long-Term Treatment of Urgency Urinary Incontinence (Business Wire)

• Neuro Event Labs Receives FDA 510(k) Clearance for the Nelli Seizure Monitoring System (Neuroeventlabs)

• Focused Cryo announces that the Focused Cryotherapy System is now FDA 510(k) cleared (Linkedin)

• Neurovalens wins FDA de novo approval for weight management neurostim device (Mass Device)

• PathMaker Neurosystems Receives FDA Breakthrough Device Designation For Use of the MyoRegulator® Neuromodulation Device in ALS For Slowing the Progression of Functional Symptoms (Globe Newswire)

• Ceribell receives US FDA Breakthrough Device designation for in-hospital LVO stroke detection monitor (NeuroNews)

• Revision announces FDA Breakthrough Designation for vision implant (LinkedIn)

• NeuroPace Files PMA Supplement to FDA Seeking Expanding RNS System Indication for Idiopathic Generalized Epilepsy (Yahoo Finance)

• Nexalin Technology Completes FDA Q-Submission Meeting for Gen-2 SYNC Neurostimulation Console in Alzheimer’s Disease Program (Nexalin Technology)

• Use of Real-World Evidence for Medical Device (FDA | Linkedin)

• FDA Quarterly Performance Tracker (Tufts CDD)

• What the 2026 Medicare Final Rules Mean for Neuromodulation and Pain Practices - (NANS)

• Director of NIH neurological disorders institute is ousted, adding to leadership churn (Stat News)

• FDA Clears BrainSpace Intellidrop, an automated neuro device that addresses ICU nursing shortages and builds training data for Physical AI (PR Newswire)

  • Market map from BrainSpace’s CEO & Co-founder Caitlin Morse

    

    Source: Caitlin Morse, LinkedIn

• FDA’s Mindset Shift for AI-powered Health Solutions and Wearable Wellness Products (Mittal Consulting)

Industry

• Science Corp: Restoring Vision for Patients with AMD and Geographic Atrophy (NEJM | Morningstar)

• Setpoint Medical’s Vagus nerve-mediated neuroimmune modulation for rheumatoid arthritis: a pivotal randomized controlled trial (Nature)

• NeuroXess: China Tests Its First Fully Implanted Brain-Computer Interface (Pandaily)

• Internet of Brains: A Blueprint for Connecting the Brain to the World (Linkedin | IOB)

• Datasea Announces Major Acoustic Technology Advancements in Brain-Computer Interface Applications (PR Newswire)

• AI-Stroke joins Stanford’s StartX accelerator (NewFund)

• Neurotech Firms Pursue Advances in Wireless Energy Transfer (Neurotech Reports)

• NBR Editors Interview BCI Researchers at Neuroscience 2025 (Neurotech Reports)

• Nanotechnology in the Military Domain: A Primer (UNIDIR)

• Inside Sutter’s plan to make interventional psychiatry the new standard (Becker’s Behavioral Health)

• Ultrasound Treatment Takes on Cancer’s Toughest Tumors (IEEE Spectrum)

• AI device shortens autism diagnosis time: Study (Health IT)

• EU rewires its brain health investment model, but scaling challenge remains (Euractiv)

• Nerve-stimulating wearable targets heavy menstrual bleeding without drugs, hormones (Interesting Engineering)

• A Brain-Computer Interface Company is Getting into Organ Preservation (WIRED)

• Canada Can Lead the World in Spinal Cord Injury Research – If We Keep Investing (Tech Couver)

• What does Neuralink want – to help people with paralysis, or prepare for a war with AI? (STAT 10)

• HyperX and Neurable Are Trying To Make Your Brain Better At Gaming (IGN)

• Nia Therapeutics Publishes Peer-Reviewed Validation of a 60-Channel Brain Implant for Closed-Loop Neurostimulation (Business Wire)

• The most exciting AI wearable at CES 2026 might not be smart glasses after all (ZD Net)

• Paradromics Completes First-In-Human Recording with the Connexus Brain-Computer Interface (Linkedin | Paradromics)

• This Earbud Could Rival Neuralink. Its Investor Just Needs to Build a Business First (Inc)

• The CES companies hoping your brain is the next big thing in computing (Engadget)

• Cerebro Clinical-Grade AI Deployment Playbook (Cerebro Neurotech)

• The Wearables Inflection Point by Blythe Karow (Substack)

• Cahira: How Our Own Cells Could Implant The Next Generation Of Nonsurgical Brain Microchips (Forbes)

• Cumulus: A brief visual evoked potential (VEP) modulation assessment of experience-dependent plasticity recorded via wireless dry-EEG headset in Phase 1 clinical units (Nature)

• Nexalin: Published Peer-Reviewed Study Demonstrates Nexalin’s DIFS™ Neurostimulation Improves Attention and Normalizes Brain Activity in Patients with ADHD (Nexalin)

• Meta: Enabling Skilled Human-Computer Interaction After Paralysis via a Wearable sEMG Interface (biorxiv)

• Fareon: Transcranial microtesla magnetic fields suppress neuroinflammation and neuronal oxidative stress burden (Cell)

• US FDA approves home-delivered tDCS for treating depression (Brain Stimulation)

• Carthera: Faster Approach Determines Brain Cancer Treatment Is Working (OncLive)

📺Neurotech.TV

• FusForward Episode 8: Self experimentation (Linkedin)

• How do phobias magnify, and how do psychiatrists try to intervene? (David Eagleman)

• Muscles and machines. Connor Glass on new approaches to prosthesis control (Ottobock)

• Neuromodulation for Treatment-Resistant Depression with Jean-François Aubry, PhD (Curing with Sound)

• Is this the year for precision psychology? With Amit Etkin (PharmaPhorum)

Society

• 2025 Existential Hope Meme Prize Winner (Existential Hope)

• Brain organoids are helping researchers, but their use also creates unease (NPR)

• The Neurotechnology Shift: how next-generation wearables interface with the brain itself (The Conversation)

• NATO Chief Scientist Report on Cognitive Warfare (NATO)

• The Brain Is the Rate-Limiting Organ of Longevity: A Brain-First Systems Framework for Aging (Cureus)

• Neuroarts: At the Intersection of the Arts, Research, Technology, and Practice (Leonardo)

• Neuroscientists dive into the gut (Stanford)

• Translating digital and AI advances into brain health outcomes (European Policy Centre)

• Which emerging neurotech will have the biggest real-world impact in the next decade? (IEEE)

  

Research

• A multimodal sleep foundation model for disease prediction (Nature)

  • Nice summary from Nandan Lad: One Night of Sleep. 130 Diseases Predicted

  

• Japanese scientists just built human brain circuits in the lab (Science Daily)

• Stimulant medications affect arousal and reward, not attention networks (Cell)

• Why doesn’t neuroimaging work in psychiatry? (Cambridge U Press)

• Interpretation Issues With the Patient Health Questionnaire Instructions (JAMA Psychiatry)

• The breakthrough discoveries for thriving with bipolar disorder (BD2) integrated network longitudinal cohort protocol (Springer Nature)

• Chronic Pain is a Brain Network Disorder (JAMA Neurology)

• An EMG Foundation Model for Neural Decoding (BioRxiv)

• Cortical potentials evoked by stimulation of cervical vagus vs. auricular nerve: a comparative, parametric study in nonhuman primates (BioRxiv)

• Leveraging insights from neuroscience to build adaptive artificial intelligence (Nature Neuroscience)

• Longitudinal associations of electroconvulsive therapy with all-cause mortality and suicide deaths in severe unipolar or bipolar depression: a systematic review and meta-analysis (PubMed)

• Evaluation of neuropsychological, psychiatric, and inflammatory processes to the expression of subjective cognitive symptoms in post-acute COVID-19 syndrome (Frontiers)

• Single-Day versus Once-Daily TMS in Depression: A Propensity-Matched Comparison of Treatment Outcomes (Research Square)

• Data-Driven Feedback Identifies Focused Ultrasound Exposure Regimens for Improved Nanotheranostic Targeting of the Brain (Advanced Science | Commentary & Summary)

• A Systematic Review and Meta-Analysis of EEG, fMRI, and fNIRS Studies on the Psychological Impact of Nature on WellBeing (Preprints.org)

• Neurobiophilia (Brain Sciences)

  

  On that note…time to go for a walk! Source

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That’s a wrap! What did I miss? Send news + tips + suggestions for next time.