The US Food and Drug Administration has cleared Precision Neuroscience’s Layer 7 Cortical Interface to remain implanted for up to 30 days. Its previous 510(k) clearance limited the electrode array to intraoperative use lasting no more than 30 minutes.
The longer implantation window allows researchers to collect neural data over days and weeks rather than during a single procedure. It also creates an intermediate regulatory step between short-term surgical use and the company’s longer-term goal of a permanently implanted interface.
Why it matters
Layer 7 is the first thin-film cortical electrode product to receive clearance for this length of implantation. The decision provides a useful regulatory reference for other companies developing flexible cortical interfaces, including NeuroXess and StairMed in China.