Neurotech Notables #45: December 1-15, 2025
Deck The Halls & Stack the Deck
Season’s Greetings Dear Readers,
There’s no place like home for the holidays. We’re here: our final biweekly roundup of the year before we take a break until 2026. More on that below; First, here are some of the most notable headlines of the past two weeks:
Neuralink hired David McMullen from the FDA and reached their 19th patient. Science Corp’s new C-Suite moves indicate bold swings ahead. An IPO duo Down Unda and more across funding and commercial deals in BCI, implanted neurotech and beyond.
Flow Neuroscience got a major FDA Clearance to reimagine treatment for major depression. Radial brings frontier psychiatry to the fore with $50m as Magnus grows their provider network.
USFG also dropped new funding Big (NSF) and Small (NIDA), as well as entirely new health tech programs in ACCESS and TEMPO. ARIA-backed Cambridge Neuroworks launches blue sky funding program. Closer to home, Astera announced a new $600m neuroAI lab in my backyard.
Reports: New two-part market report from Araya. Neurology and Psychiatry market analysis. FDA TAP program review and AI data. Updated BCI meta analysis. Investor analysis from a number of angles.
Gear Up: Introducing a new midroll section! Scroll there for details on registering for our JPM party on Jan 12, our new placement and advisory services, and how to partner with us in 2026.
Plenty more afoot at Neurotech Futures going into the new year. You’ve given me the best gift any writer could hope for: Dedicated Readers. So watch this space. Until soon, rest up. Thanks again for joining this adventure with me at some point over the past two years. I’m asking Santa for at least two more!
👋🏽 Hi, I’m Naveen. I believe brain health is human health. You are one of the 3,413 readers of my biweekly reports on emerging neurotech markets.
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Funding
Epiminder has a successful $325 million listing on ASX and $125 million capital raising (Linkedin)
Saluda Medical Raises $150M USD to Fuel Growth Following ASX IPO (PR Newswire)…Saluda’s debut day meltdown marks Australia’s weakest IPO in decades (Reuters)
Radial raises $50M from General Catalyst to treat mental health in non-traditional ways (Endpoints | Behavioral Health Business)
I want to hear all thoughts, perceptions, interpretations, and questions you have about this deal and related developments in outpatient mental and behavioral health.
Kitea Health closes $13m raise, lines up human trials in the US (NZ Herald)
NeuroBionics Announces Oversubscribed $10M Seed Round with Second Close Led by Future Ventures (NeuroBionics)
Subsense raises $10m in additional capital (Axios)
Sinaptica Therapeutics Receives Funding from The Centre for Aging + Brain Health Innovation and Baycrest to Advance Breakthrough Neuromodulation Therapy for Alzheimer’s (Sinaptica)
Cambridge NeuroWorks drives UK neurotech forward with launch of nationwide Blue Sky Proof-of-Concept Fund with backing from ARIA (Cambridge NeuroWorks)
Kadence Bio awarded a Biomedical Catalyst grant of £500,000 from Innovate UK (Linkedin)
Sonomind receives the Marcel Dassault Prize (Linkedin)
MHRA and NICE receive £2 million from Wellcome to improve safety and effectiveness of digital mental health technologies (GOV UK)
NSF announces new initiative to launch and scale a new generation of transformative independent research organizations to advance breakthrough science (NSF)
As per E11 Bio’s Jun Axup: “NSF announced Tech Labs initiative to fund ~$1B into new science and technology institutions, like Focused Research Organizations, with awards of $10-50 million/year per team!”
2025 “$100,000 Start an SUD Startup” Challenge (Challenge.gov)
Neuroscientist Doris Tsao joins Astera to lead its new neuroscience program (Astera)
Heck of an opening paragraph: “The Astera Institute is excited to launch a major new neuroscience research effort led by Dr. Doris Tsao, who will be joining as Chief Scientist for Astera Neuro. We seek to understand one of the deepest mysteries of science: how the brain produces conscious experience, cognition, and intelligent behavior. Astera will support this effort with $600M+ over the next decade.”
Praxis Neuro Next Fund: A New Way to Invest in Disability (Praxis Neuro)
From our friends at Praxis SCI. What do you think?
Commercial
Neuralink picks FDA leader to head up medical affairs (Mass Device | Neuralink)
Science Corporation Names Darius Shahida as Chief Strategy Officer (BusinessWire)
Science also appointed Alan Mardinly as Chief Science Officer and Frank Brodie, M.D. as Medical Director for Vision and PRIMA
INBRAIN Neuroelectrics Appoints Scott Heunnekens as Chairman of the Board (Business Wire)
IDUN Technologies x BRNLIT.AI announce official collaboration (Linkedin)
DexMat, Inc. Secures Landmark Offtake Agreement with NeuroBionics for Galvorn® Carbon Nanotube Fiber, Advancing Minimally-Invasive Neuromodulation Platform (DexMat)
Bio-Techne Partners with the Wyss Center Geneva to Advance Automated 3D Multiomics Technology and Accelerate Spatial Biology (PR Newswire)
Leading Mid-Atlantic Insurance Provider Published New Coverage Policy for Nerivio REN Wearable, Granting 3.4 million People with Access to Drug-Free Migraine Care (PR Newswire)
Features Capital Powers Launch of Resonant Link Medical to Transform the Future of Implantable Devices, Appoints Omari Bouknight as CEO and Raymond Cohen as Board Chair (Cision Newswire)
Cortigent files amendment to S-1 (SEC)
NeuroLight Announces Corporate Restructuring to Accelerate Development of Prevention and Treatments for Alzheimer’s, PTSD, and Sleep Disorders (NeuroLight)
Magnus adds Sutter Health to network of verified providers for SAINT TMS (LinkedIn)
🆕Pinned Promo & Party📍
Starting in January Notables will offer paid placements in this section. We’ll feature updates from startup firms and operators seeking creative ways to raise their profile and spark collaboration. I’ll kick things off this month.
🥂Neurotech Futures invites you to a new years party in San Francisco to kick off JPM week. Predictions, raffle, & drinks. Open to all but venue will have a cap on spots so there could be waitlisting. Register today!
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Regulatory & Federal
US FDA approves Flow’s first at-home device for depression (Linkedin | Reuters)
Medtronic earns expanded FDA nod for dystonia deep brain stim (Mass Device)
Natus announces FDA 510(k) clearance for electrographic status epilepticus diagnostic indication in BrainWatch point-of-care EEG solution (PR Newswire)
Total Product Lifecycle Advisory Program (TAP) Pilot Assessment Final Assessment Report (FDA)
Medical Devices that Incorporate Sensor-based Digital Health Technology (FDA)
Characterizing industry payments for FDA-approved AI medical devices (Health Affairs Scholars)
FDA Launches TEMPO: A First-of-Its-Kind Digital Health Pilot to Expand Access to Chronic Disease Technologies (Linkedin | FDA)
Industry
Neuralink has now implanted their devices in 19 human trial patients, including 7 patients in the United Kingdom (NeuraPod)
The First AI “Psychedelic Patient” Has Arrived (Double Blind Magazine)
Yale-Trained Neuroscientist Unveils ‘Lume’: An 8-Minute Nasal Neurotechnology to Revolutionize Sleep (CBS 42)
Johnson & Johnson MedTech to shift to business unit-led structure in 2026 (Mass Device)
Inner Cosmos: Clinical Trial Update - FDA Early Feasibility Study Completion (Inner Cosmos)
After Neuralink, Max Hodak is building something even wilder (TechCrunch)
Cortec: In brain-implant study, patient breaks through ‘dead end’ (UWMedicine)
Detection of magnetic muscle activity in real-world conditions with Sonera’s contactless, chip-scale sensors (Sonera)
Neurive: Transcutaneous auricular vagus nerve stimulation enhances emotional bias towards happiness in healthy young adults: A comparative study of electrical and ultrasound stimulation (BioRxiv)
Dr. Shayan Moosa and Team at University of Virginia surpasses 100-target milestone using RebrAIn services for targeting treatments of Essential Tremor and Parkinson’s Disease (Linkedin)
Enhancing Asleep Deep Brain Stimulation Targeting for Essential Tremor Using Machine Learning: The OPTIVIM Phase 2 Study (Neurosurgery)
Comment from ReBrain
The state of science convergence in implantable brain-computer interface clinical trials (Journal of Neural Engineering)
Datasea Announces Breakthrough in Acoustic-Driven Brain-Computer Interface Technology (PR Newswire)
Opinion: Patient-Centered Paradigms Can Boost Neuro Candidate Success Rates (BioSpace)
A Primer on Investing in Brain-Computer Interfaces (Substack)
Why we invested in Kneu Health (OSE)
I wish more VCs wrote these notes: “In just over two years, Caroline and her team took Kneu from concept, to FDA clearance, to its first paid U.S. deployment, a pace almost unheard of for a science-driven startup. The company’s early U.S. traction also reflects OSE’s close working relationship with Cedars-Sinai, where a collaboration with the Cedars team helped Kneu get to first US patients and reimbursement much faster than any of us had anticipated.”
Araya Inc.’s Neurotech Landscape Report for 2025 (Linkedin | Araya)
This is a comprehensive exploration of both implantable and noninvasive landscapes! Check out the report sample for a look at how the “Neurotech Innovation Index” scoring system works 🤓
📺Neurotech.TV
Neuralink Overview, Fall 2025 (Youtube)
DJ Seo, discussing their 10x faster robot: “Our long term vision is to make this kind of like a LASIK Surgery, potentially you can get it during a lunch break, so you need to do this under one hour, maybe you can do it awake. We want it to become a one-click surgery, super reliable.”
A new era in neurodegeneration (Youtube)
What happens to patients when neurotechnology is abandoned? (ABC Radio National)
How ibogaine could treat depression and anxiety (TED)
Ana Montero and André Marques-Smith, CEO and CTO of Atlas (Fitt Insider)
The Race to End Cognitive Decline with Mai Nguyen, CEO of OptoCeutics (ReeThink Podcast)
Surf Therapeutics: Calming Inflammation Through Neuromodulation (Youtube | Linkedin)
The Brain Prize webinar series 2025 (Brain Prize)
Attitude: Stories about inner strength - featuring Scott Imbrie (Story Collider)
Society
Beyond ‘Bikini Medicine’: Bridging gaps in women’s brain health research (Sunnybrook)
The Next Frontier For AI Is the Human Brain (Forbes)
Depression Treated At-Home Without Meds? A First FDA-Approved Device is Here (Frontier Psychiatrists)
Streeting orders review into mental health and ADHD diagnoses (BBC)
Russia explores neurotechnology at scale beyond Neuralink (Newsgab)
When Minds Meet Machines: Cybersecurity and the Coming Age of Neurotechnology (Linkedin)
Neurotechnology on the Consumer Market (Neuroethics Today)
Nolan Williams, innovative neuroscientist who devised rapid treatments for severe depression, dies at 43 (Stanford Medicine)
Burden of Disorders Affecting the Nervous System: From the Global Burden of Disease 2021 Study (Jama)
Figure 1. Estimated Prevalence of Conditions Affecting the Nervous System in the United States in 2021 by Category (Jama)
Research
Brain’s ‘plumbing’ inspires new Alzheimer’s strategies—and controversial surgeries (Science)
Using Light to Understand the Brain (BU ENGineer Magazine)
US Packs 65,539 electrodes into paper-thin brain chip for real time testing (Interesting Engineering | Linkedin | Nature)
100% Success Rate: All 32 Paralysis Patients in China’s Brain-Computer Interface Clinical Trial Achieve Brain-Controlled Grasping (Pandaily)
Transcranial Magnetic Stimulation in Sports Performance: Promise, Physiology, and Precaution (Psychiatric Times)
Mapping the genetic landscape across 14 psychiatric disorders (Nature)
BOLD signal changes can oppose oxygen metabolism across the human cortex (Nature)
Interesting discussion on LinkedIn….
This tiny implant sends secret messages to the brain (Science Daily)
Computational whole-body-exposome models for global precision brain health (Nature Communication)
Efficacy and Safety of Neuromodulation Interventions for Autism Spectrum Disorders with Comorbidities: A Systematic Review (Dovepress)
A simplified wearable device powered by a generative EMG network for hand-gesture recognition and gait prediction (Nature)
Is glymphatic clearance the secret to restorative sleep? (BRAIN)
Multi-modal, multi-species, and multi-task latent-space model for decoding levels of consciousness (Open Review)
Hydrogel–elastomer-based conductive nanomembranes for soft bioelectronics (Nature Nanotechnology)
That’s a wrap! What did I miss? Send news + tips + suggestions for next time.