Precision Neuroscience Secures FDA Clearance for Breakthrough Brain-Computer Interface

Precision Neuroscience has obtained FDA 510(k) clearance for its Layer 7 Cortical Interface, a high-resolution electrode array for brain surface electrical activity recording and stimulation. This milestone represents the first regulatory clearance for a next-generation wireless brain-computer interface (BCI) system, authorizing commercial use for up to 30-day implantations.

The device has been tested in 37 patients across leading institutions including Mount Sinai and the University of Pennsylvania. “This clearance transforms our ability to gather neural data,” said Dr. Benjamin Rapoport, Precision’s Chief Science Officer. “Where previous recordings lasted hours, we can now study brain activity for weeks – a quantum leap for neuroscience research and clinical applications.”

Precision will expand its clinical program with new institutional partnerships this year. The technology promises to enhance intraoperative brain mapping and accelerate the development of fully implantable BCI systems. CEO Michael Mager noted: “From concept to FDA clearance in four years demonstrates our team’s ability to deliver transformative neurotechnology.”