FDA Clears Brain–Computer Interface Device for the Measurement and Stimulation of Cortical Brain Activity

The Food and Drug Administration (FDA) has granted 510(k) clearance to the Layer 7 Cortical Interface device (Precision Neuroscience, New York City, NY), a high-resolution electrode array designed to measure and stimulate cortical brain activity. The clearance authorizes the implantation of this brain–computer interface (BCI) for periods of up to 30 days. Precision Neuroscience stated in an announcement that the Layer 7 Cortical Interface is the first wireless BCI device to receive FDA clearance.

According to a statement from Precision Neuroscience, the Layer 7 Cortical Interface consists of 1024 microelectrodes embedded in a flexible film thinner than a human hair, which is designed to conform to the brain's surface without penetrating tissue.

To date, the device has been temporarily implanted in 37 clinical study participants through research partnerships with Beth Israel Deaconess Medical Center, West Virginia University’s Rockefeller Neuroscience Institute, Perelman School of Medicine, and the Mount Sinai Health System. During these studies, the Layer 7 Cortical Interface was used to map electrical activity with high resolution while participants underwent neurosurgical procedures.

“Neural decoding algorithms, like all AI-driven products, rely on vast amounts of data,” said Benjamin Rapoport, MD, PhD, Chief Science Officer and Cofounder of Precision Neuroscience. “This regulatory clearance will exponentially increase our access to diverse, high-quality data, which will help us to build BCI systems that work more effectively.”