FDA Approves Neuralink Rival's Brain Implant

Forbes

17-04-2025

The Food and Drug Administration on Thursday approved a core component of a brain implant made by Precision Neuroscience, a company created by a cofounder of Elon Musk's Neuralink that claims its implant could be used to assist patients with severe paralysis—a clearance that comes as biotech companies reportedly face challenges for regulatory approval under the Trump administration.
Precision Neuroscience said its brain implant system could help patients with severe paralysis.
Precision said Thursday the FDA approved its Layer 7 Cortical Interface, a component of the company's brain-computer interface implant that helps record, monitor and stimulate electrical activity on the brain's surface.
The FDA's clearance allows Precision to implant Layer 7 in patients for up to 30 days and market the technology for use in clinical applications, including during procedures to map brain signals, the company said.
Precision announced it will expand its clinical research program for the implant, after the company had already tested the device in 37 patients, as the FDA's approval allows Precision to collect data over weeks instead of hours.
A spokesperson for Precision told Bloomberg the company expects to start selling the device in 2026 (Precision did not immediately respond to a request for comment from Forbes).
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Precision's Layer 7 implant is a small, yellow device thinner than a piece of hair made up of 1,024 electrodes, or a conductor that carries electrical signals. The electrodes can detect electrical activity on the brain's surface, allowing researchers or medical practitioners to better observe which parts of the brain are in use, according to Precision. The company has marketed its implant as minimally invasive and claims the product could restore functions like speech and movement among patients with paralysis.
Some clinical trials and drug tests by biotech companies have been delayed as mass layoffs impair functions at the FDA, people familiar with the matter told The Wall Street Journal. One company, Daré Bioscience, told the Journal a late-stage study of a treatment for a sexual-arousal disorder in women was delayed indefinitely, as the FDA has pushed back a date when it would provide guidance on how to measure the study's results. The FDA said in a statement to Forbes the agency is 'actively working to ensure continuity of operations during the reorganization period and remains committed to ensuring critical programs and testing continue.'
Benjamin Rapoport cofounded Precision Neuroscience in 2021, four years after he helped cofound Musk's Neuralink. Precision is one competitor for Musk's brain implant company, including Blackrock Neurotech and Synchron, a company backed by Amazon founder Jeff Bezos and Bill Gates. Precision raised about $102 million in venture capital funding in December, bringing the company's total funding to $155 million.
Neuralink implanted a brain chip in its first human subject last year, and the company has since implanted two other patients as of January, Musk said. Musk said the company expected to implant between 20 and 30 more patients in 2025, as Musk has claimed Neuralink's implant could bestow 'cybernetic powers' on people and allow people to control robots with their mind. He has also claimed the device could help treat epilepsy and fully cure paralysis, an issue Musk said is a 'tough problem, but ultimately solvable.' Some experts have criticized Neuralink for its lack of transparency, however, as some raised questions about patient safety and risks pushing back the neurotechnology industry.
Elon Musk's Neuralink Prepares To Implant Second Human Patient (Forbes)