Precision Neuroscience receives FDA clearance for brain implant

Precision Neuroscience has received FDA 510(k) clearance for its Layer 7 Cortical Interface, a thin microelectrode array designed to map brain activity for up to 30 days. This clearance marks a key milestone for the New York-based startup, which is developing a brain-computer interface (BCI) system. The Layer 7 device rests on the surface of the cerebral cortex and is implanted through a small skull incision. It has been tested in 37 patients during temporary placements for procedures like brain tumor removal. With this FDA approval, the device can now be used for longer-term intraoperative brain mapping, enabling the company to collect high-resolution neural data. Precision plans to use this data to train algorithms for future BCI applications, such as controlling robotic limbs. The company is among the first to gain FDA clearance for a next-generation wireless BCI, positioning itself alongside competitors like Neuralink and Synchron, which has already begun human trials.

28-04-2025