The Layer 7 thin-film brain-computer interface (BCI) features 1,024 electrodes embedded in a flexible film that conforms to the brain surface. The film comes in at one-fifth the thickness of a human hair. This device aims to help users with severe paralysis operate digital devices, like computers and smartphones, using their thoughts.

Layer 7 constitutes a core component of Precision Neuroscience’s fully implantable, wireless BCI system under development. With the clearance, Layer 7 now has the green light for commercial use with implantation durations of up to 30 days.

Precision Neuroscience says the clearance marks “a major milestone” in the BCI field. The company says it’s the first full regulatory clearance granted to a company developing a next-generation wireless BCI. It provides a leg up in the BCI market for Precision, which is going up against the likes of Neuralink, Synchron and others in the growing space.