10 articles
The ExaStim system — a transcutaneous spinal cord stimulator for people with chronic spinal cord injury — has received FDA 510(k) clearance, making it the first device of its kind cleared for both clinical and home use in the United States.
The Melbourne-based startup has received FDA approval to begin a first-in-human study of Phantom X, an implanted sensor array that reads neuromuscular signals from a residual limb without entering the nervous system — aiming to give amputees more natural prosthetic control.
The Austin-based company is now enrolling participants at the University of Michigan and Massachusetts General Hospital for the Connect-One study, the first clinical trial of a fully implantable BCI designed to restore speech.
The Pennsylvania company's 60-channel Smart Neurostimulation System is the first device to receive Breakthrough Device Designation for TBI-related memory loss.
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.
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.
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.
A Health Affairs analysis argues that CMS needs a dedicated coverage pathway for implantable BCIs before the technology outpaces the reimbursement system that patients depend on.
The Leuven-based neurotech company's Occular system, which uses thousands of micro-electrodes implanted in the visual cortex to restore functional sight, has received FDA Breakthrough Device Designation.
FDA grants approval for Neuralink to enroll significantly more participants in its brain-computer interface clinical trials, marking a major step toward commercialization.
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