U.S. Food and Drug Administration

The FDA has cleared Precision Neuroscience's Layer 7 Cortical Interface to stay implanted for up to 30 days, up from a previous 510(k) limit of 30 minutes of intraoperative use. The longer window opens the door to extended clinical studies and marks an intermediate step toward a permanent implant.

The FDA issued final guidance in 2021 on implanted brain-computer interface (BCI) devices for patients with paralysis or amputation, covering nonclinical testing and clinical study design.