News
Synchron Returns to Melbourne for First Trial of Next-Generation Stentrode
The FOCUS-AU trial will test Synchron's advanced brain-computer interface in ten MND patients across three Australian hospitals, with surgery beginning in April.
Industry News
China's Beinao-1 Reaches Five Patients With Semi-Invasive Brain Chip
Five patients now carry the coin-sized wireless implant that sits on the brain's protective membrane rather than penetrating tissue, with one ALS patient decoding nearly 100 Chinese words.
Industry News
Nia Therapeutics Wins FDA Breakthrough Designation for AI-Guided Memory Implant
The Pennsylvania company's 60-channel Smart Neurostimulation System is the first device to receive Breakthrough Device Designation for TBI-related memory loss.
Market Moves
Cambridge Innovation Institute Acquires Neurotech Reports After 25 Years of Independent Publishing
CII absorbs the neurotechnology sector's longest-running trade publication into its venture and innovation division, with founder James Cavuoto and team staying on.
Market Moves
Cleveland Startup Sells $350 Brain Stimulation Headset Without FDA Clearance While Clinical Trials Continue
U: The Mind Company began taking orders for a consumer neuromodulation device on March 18, marketing bold clinical claims that have not appeared in peer-reviewed literature. An FDA submission is planned for 2027.
Industry News
Flow Neuroscience Brings First FDA-Approved At-Home Brain Stimulation for Depression to US Market
The Swedish company's FL-100 headset, cleared via the FDA's most stringent PMA pathway, launches in the US in Q2 2026 after a 174-person Nature Medicine trial. A second device, Neurolief's ProlivRx, was approved weeks later.
Research
Spinal Cord Stimulation Restores Both Movement and Sensation in Complete Paralysis for the First Time
A Brown University-led trial published in Nature Biomedical Engineering demonstrates simultaneous motor and sensory restoration in three people with complete spinal cord injuries using patterned electrical stimulation and machine learning.
Research
Brain Implants Malfunction at Night, Dutch Study Reveals Critical Gap in Round-the-Clock BCI Use
A UMC Utrecht study found that a brain-computer interface trained on daytime neural signals produced 245 false commands per hour when the patient slept, exposing a fundamental problem for 24/7 assistive devices.
Policy & Regulation
FDA's One-Trial Default Lands Just as BCI Companies Approach Pivotal Studies
The agency's new policy ending the two-trial requirement was written for drugs, but brain implant makers watching Synchron, Neuralink, and Paradromics navigate FDA are asking whether the same logic could eventually ease their path.
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