FDA grants 510(k) clearance to Layer 7 Cortical Interface for use up to 30 days

Precision Neuroscience/Layer 7 Cortical Interface

Precision Neuroscience received 510(k) clearance from the FDA for its Layer 7 Cortical Interface, a thin-film electrode array that sits on the brain's surface for recording, monitoring and stimulation for up to 30 days. The clearance authorizes the first full regulatory approval for a next-generation wireless brain-computer interface and enables intraoperative brain mapping and monitoring.

• Device features 1,024 electrodes embedded in flexible film, one-fifth the thickness of human hair, conforming to brain surface without penetrating tissue.
• Tested in 37 clinical study participants across four institutions: Beth Israel, WVU, Penn, and Mount Sinai; used for intraoperative mapping during neurosurgery.
• Cleared for 30-day durations, enabling clinical applications such as brain mapping during tumor resection and monitoring intracranial pathology.