Precision Neuroscience has received FDA 510(k) clearance for its Layer 7 Cortical Interface. This high-resolution cortical electrode array is a key component of their brain-computer interface (BCI) system. The FDA has authorized it for commercial use for up to 30 days.
The Layer 7 interface features 1,024 electrodes on a thin, flexible film. It is designed for minimally invasive insertion through a sub-millimeter incision on the surface of the brain. This allows for recording, monitoring, and stimulation of electrical activity.
The FDA clearance enables Precision Neuroscience to market its technology for clinical applications. These include intraoperative brain mapping and gathering high-quality neural data. The company plans to expand its clinical research program, building on the 37 patients who have already tested the device.