“Precision Neuroscience has obtained an FDA clearance for a crucial piece of its plans for a full brain-computer interface system, starting with its minimally invasive cortical electrode array. The company described it as the first regulatory green light for a developer of wireless mind-reading tech.

The agency cleared Precision’s Layer 7 interface as a temporary implant for use up to 30 days. Built on a thin, flexible film, the device and its 1,024 electrodes can be slotted through a sub-millimeter incision and placed nearly anywhere on the surface of the brain in a reversible procedure. It is capable of recording information as well as stimulating neural activity, and multiple implants have been used in a single patient.

The company said the go-ahead from the FDA will allow it to begin offering the device for medical applications such as brain mapping during open surgery, as it continues to develop its computer-controlling platform.”

From Fierce Biotech.