Greetings Readers,
Neurotech’s busy summer continues through Labor Day weekend.
In the back half of August, we saw more than $130m in new funding, along with major commercial updates spanning leadership changes and appointments, closures, launches, acquisitions, partnerships, clearances, new reimbursement codes, and more.
Not to mention: Some great podcasts and bold perspectives on leadership, strategy, ethics, and regulation. It’s open season for free education on business and beyond…
Fresh articles in the pipeline here, too, so stay tuned for guest contributions, expert Q&As, deep dives, and our second teardown in the coming weeks.
As always, hit reply with feedback, ideas, suggestions, or questions. Enjoy the reading, listening, learning, and the short week ahead.
Funding
Openwater raises $54M for open-source medical research technology (Axios | Inside Precision Medicine)
XII Medical raises $45m Series B for Obstructive Sleep Apnea Neuromodulation (PR Newswire)
Neuspera Medical Closes $23M Series D Funding Round (MPO)
Piramidal launches from YC with $6M to Expand Foundational AI Brain Model for Neurologists (HIT Consultant | TechCrunch )
Neurobionics announces NSF grant and pre-seed round from Dolby Family Partners (LinkedIn)
PsychoGenics Inc. Awarded $3 million SBIR Grant to Employ its AI-enabled Platforms to Find Treatments for Rare Disorders (Psychogenics)
Massachusetts AI and Technology Center for Connected Care in Aging and Alzheimer’s Disease Funds 11 Pilot Projects Totaling $2.3 Million (UMass)
DARPA Launches Regional Commercial Accelerators (DARPA)
Commercial
Cognito Therapeutics Appoints Christian Howell as Chief Executive Officer (Business Wire)
SEER medical announces closure of clinics across Australia due to recall, with no services for “an estimated 1-2 years.” (LinkedIn)
Penumbra axes virtual reality division, will lay off 71 people (MedTech Dive)
Osmind adds Husseini Manji, M.D., F.R.C.P.C., as Strategic Advisor (LinkedIn)
BrightMind.AI appoints Peter McAllister, M.D., to clinical advisory board (LinkedIn)
Neurosoft Bioelectronics hires Alexandre Michalis as new Head of Product Development (LinkedIn)
Healium Adds Integration with Muse 2 by Interaxon for EEG data (Healium)
PursueCare relaunches Pear’s Digital Therapeutics apps (STAT)
CoachCare & NXTSTIM Collaborate to Offer World’s First Commercial RPM Solution for Pain Management (CoachCare)
Firefly Neuroscience Forms Strategic Partnership with Neurology Consultants of Dallas (NCD) to Enhance Early Detection Efforts and Disease Management for Patients with Cognitive Disorders (BioSpace)
NeuraWorx Partners with Corundum Neuroscience to Initiate Clinical Feasibility Study, Develop Innovative Neurological Disease Treatment (PR Log)
From July: Science Corp. set to expand RTP facility (NCBiotech)
Lenire Controlled Clinical Trial Results Published in Nature Communications (Lenire | Paper)
Barostim: CAMC first in southern West Virginia to implant world’s first neuromodulation device (59 News)
Stryker announces definitive agreement to acquire Vertos Medical (Healio)
Flow tDCS to be available to eligible West London NHS Trust patients (LinkedIn)
MemoryCareAI selected for StartUp Health Alzheimer's Moonshot Program (LinkedIn)
Regulatory
RebrAIn announces 510k for OptMRI software (LinkedIn)
Neuros receives FDA Approval for the Altius Direct Electrical Nerve Stimulation System (PR Newswire)
Noctrix Health Announces New CMS Reimbursement Codes and Payment for Nidra Tonic Motor Activation (TOMAC) Therapy for Restless Legs Syndrome (RLS) (Yahoo)
Wexton and Bilirakis Introduce Bipartisan HEALTHY BRAINS Act to Advance Research into Neurodegenerative Diseases Risks (Wexton)
Spark Biomedical Has Been Issued New CMS Codes for Transcutaneous Auricular Neurostimulation (tAN® ) Therapy via Sparrow Ascent (Spark Biomedical)
ARPA-H News:
Results from Medical Imaging Data Marketplace Survey (Summary | ARPA-H)
New ARPA-H Program Manager Jean Hebert (MIT Technology Review | ARPA-H)
New Program Manager Bradley E. Karlin, Ph.D., MBA (ARPA-H)
CDRH Taps Former Industry Exec, Surgeon to Run Evaluation and Quality Office (My Strategist)
Centers for Medicare and Medicaid Services (CMS) recognizes traumatic brain injury (TBI) as a chronic health condition for C-SNP in Medicare Advantage (LinkedIn)
MedRhythms Announces New CMS Reimbursement Code for InTandem® Rehabilitation System For Chronic Stroke Gait Impairment (PR Newswire)
Focused Ultrasound for Low Back Pain Approved in Canada (FUS Foundation)
Events
The full list is now anchored.
🗽Hello, New York! 🎃
I’ll be moderating a panel of brilliant speakers following Dr. Kevin Tracey’s morning remarks at the Biofuture Conference Oct 28-30 in NYC. Details soon; Register today.
I’ll also be at Mount Sinai’s New York BCI Symposium. Reach out to meet up!
NEUROTECH.FM
Navigating FDA clinical trials in Neurotech with Tim Marjenin (PsyMed)
Podcasts: Restoring Lost Speech (NEJM)
Podcast: Engineering Mental Health with Amit Etkin of Alto Neuroscience, Maryam Shanechi of USC, and Prasad Shirvalkar of UC San Francisco (Paradromics)
Sinaptica’s scientific co-founder Emiliano Santarnecchi at AAIC24 (Startup Health)
David Constantine of Juniper Biomedical (Mullings Group)
Leanne Williams: Depression's distinctive fingerprints in the brain (Stanford)
Industry Buzz
Alto: Opportunities for use of neuroimaging in de-risking drug development and improving clinical outcomes in psychiatry: anindustry perspective (American College of Neuropsychopharmacology)
PRIME Study Progress Update — Second Participant (Neuralink)
Expect another big deep brain stimulation tech advance from Medtronic soon (Medical Design and Outsourcing)
5 innovative ways to bring DHTs to market successfully (DiME Society)
BRAIN-funded study finds self-adjusting brain pacemaker may help reduce Parkinson’s disease symptoms (NIH BRAIN | Paper in Nature Medicine | NYTimes)
ViviStim: Arizona man using Banner Health device to help with stroke recovery (AZ Family)
Quicker, more intense brain stimulation begun at MUSC shows success in depression (Post & Courier)
Microsoft invents devices that are designed to support Brain-Computer Interfaces for monitoring health & to assist users at work and play (Patently Apple)
Why Sound Therapy Is Nature’s Psychedelic (Elle)
Precision: Brain-Computer Interfaces in Neurocritical Care: The Layer 7 Cortical Interface (Currents)
Flow: Making tDCS an accessible treatment for depression (Hemingway Report)
InnerCosmos: Pioneering Depression Treatment With Groundbreaking Brain-Computer Interface (BCI) + AI (Forbes)
Clinic of the Future Part IV: A Brief Primer on Emergent Neurotechnologies (Trip Report)
Non-invasive Brain-Computer Interfaces: State of the Art and Trends (IEEE)
Payers More Open to Covering TMS (Behavioral Health Business)
Koneksa: Regulatory Pathways for Qualification and Acceptance of Digital Health Technology-Derived Clinical Trial Endpoints: Considerations for Sponsors (Clinical Pharmacology and Therapeutics)
Neuroethics & Society
Couple sues Atlanta hospital for allegedly losing part of patient's skull following brain surgery (NBC)
Brain implants to treat epilepsy, arthritis, or even incontinence? They may be closer than you think (Guardian)
Saskia Hendricks: The Emerging Ethics of Innovative Brain Research (Undark)
A Call for a New National Institute for Longevity and Aging Research (Alliance for Longevity Initiatives)
Podcast: Agency in the Age of Science (Neuroethics Today)
Research
An Entire Brain-Machine Interface on a Chip (EPFL News)
Digital biomarkers for precision diagnosis and monitoring in Parkinson’s disease (Nature)
An Accurate and Rapidly Calibrating Speech Neuroprosthesis (NEJM)
Fast depressive symptoms improvement in bipolar I disorder after Stanford Accelerated Intelligent Neuromodulation Therapy (SAINT): A two-site feasibility and safety open-label trial (Journal of Affective Disorders)
Attune: Thalamic transcranial ultrasound stimulation in treatment resistant depression (Brain Stimulation | LinkedIn )
SPRINT® PNS Demonstrates Robust Results in Addressing Chronic Shoulder Pain (SPR)
Vielight: Modifying Alzheimer’s disease pathophysiology with photobiomodulation: model, evidence, and future with EEG-guided intervention (Frontiers in Neurology)
Brain aging patterns in a large and diverse cohort of 49,482 individuals (Nature Medicine | Nature )
What accelerates brain ageing? This AI ‘brain clock’ points to answers (Nature)
“One possible source of inconsistency in the data is the range of fMRI machines and EEGs — spread across 15 nations — that supplied the brain scans…“We need to understand this diversity,” says Ibañez. “We cannot create a truly global science of dementia without addressing this.”
Comparing Conventional Medical Management to Spinal Cord Stimulation for the Treatment of Low Back Pain in a Cohort of DISTINCT RCT Patients (Journal of Pain Research)
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