Welcome to edition 34.
The FDA told NeuroPace its PMA supplement is not approvable without more evidence, so the RNS System will not expand into drug-resistant idiopathic generalised epilepsy yet. NeuroPace plans to go back with more from the NAUTILUS trial. Rejections rarely get written up, so it is useful to see one.
Three separate access stories landed in the same fortnight. GrayMatters Health added a payor advisor for Prism. Neura Health went in-network with Cigna in all fifty states. Inspire Medical hired an SVP for market access and clinical affairs.
Funding came to roughly $80 million. A Shanghai BCI company founded in February raised RMB330 million in a record angel round. Aurenar, SeeTrue and Epitel also raised.
On the clinical side, splenic nerve stimulation produced remission-level results in rheumatoid arthritis, a 5,376-channel recording platform was published, and Motif opened enrolment for RESONATE.
The leadership section is long this time, including two appointments at Reach Neuro
Funding News
Aurenar Closes $5.7M Oversubscribed Seed Round
Shanghai BCI Startup Raises Record RMB330M Angel Round
SeeTrue Secures €2.2M Funding Led by ZEISS Ventures
Epitel Secures $26M Series B for Remote Wireless EEG
FDA News
VoxNeuro Receives FDA Clearance for cfNI Brain Assessment
NeuroPace Receives FDA Guidance on RNS Epilepsy Expansion
Autonomix Expands Neuromodulation Platform With New U.S. Patent
GrayMatters Health Adds Payor Advisor for Prism PTSD Expansion
Neura Health Enters Cigna Network Nationwide
Clinical News
Insomnia: Subjective to Physiological Signature
Human Sleep Project: Largest Lifespan Polysomnography Dataset
Splenic Neuromodulation Trial Promising for Rheumatoid Arthritis
High-Channel-Count Neural Recording Platform With 5376 Channels
Motif Neurotech’s Resonate Study Now Active and Enrolling
Researchers Complete First-of-Its-Kind Vagus Nerve Map
Cumulus’ 2-Min Digital Task Outperforms Alzheimer’s Benchmarks
Apollo Neuro TVS Extends Sleep Time Dose-Dependently
Spinal Cord Stimulation Improves Arm Control After Stroke
Focused Ultrasound Boosts Human Cognitive Attention
Accelerated rTMS Improves Cognition, EEG, Biomarkers in Alzheimer’s
Scaling Ultrasonic BCIs Beyond the Lab
Advancing Data Protections for Implantable Brain-Computer Interfaces
Road Traffic Noise Linked to Parkinson Risk
Neurologists Call for Earlier MMN Identification
Saluda Medical Announces First U.S. CAP24 Paddle Lead Surgeries
Commercial Collaborations and Launches
NERON AI Gives the Brain a Score for Cognitive Reserve
Amae Health Partners with Google Health on Wearable Integration
Ozlo Launches Sleepbuds 2 with Improved Battery and Sleep Features
TBC Releases Neurally-Optimised AI Software Proof of Concept
Augmental Introduces VOX Skin-Wearable Microphone
Three-Year Epilepsy Dialogue Engages Neuroscience Community
Neuroscape and Samsung Partner on Lifespan Cognitive Study
Arkane Capital Launches First Checks in Neuro, Energy, Logistics
Leadership Appointments
Max Ladow Joins Voaige as Founding Neuroscientist
Brittany Kuehl Joins Precision Neuroscience as Senior TPM
Science Corp. Names Nevada Sanchez EVP of Engineering
Danielle DeSouza Named CSO at Acacia Clinics
Motif Neurotech Appoints Odell Roberts Jr. Director of Quality
Bradly Stone Joins Beacon Biosignals as Senior Neuroscientist
Inspire Medical Appoints Peter Lynch SVP, Market Access
Dr. Miriam Rubelt Joins Brainlab as Clinical Affairs Director
Reach Neuro Appoints Jennifer Ernst as CEO
Brianna Hood Promoted to Head of Clinical Care Management at Rune Labs
ANT Neuro Appoints Dominik Dietze General Manager EMEA
Reach Neuro Appoints Jordi Parramon Chairman
Naqi Logix Appoints Aly Sidi as CTO
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