Precision Neuroscience wins FDA clearance for BCI cortical interface (2025)

Precision Neuroscience announced today that it received FDA 510(k) clearance for its Layer 7 cortical interface for BCI technology.

TheLayer 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.

(Precision Neuroscience is featured on our2023 list of BCI companies you need to know. You can also check out our lists of BCI companies to know from2022and2024.)

Clearance also enables Precision to begin marketing its technology for clinical applications, such as intraoperative brain mapping.

“This is a foundational moment for Precision,” said Dr. Benjamin Rapoport, chief science officer and co-founder. “By introducing the Layer 7 Cortical Interface into clinical settings, we’ll be able to deliver immediate value for patients and neurosurgical teams, enabling real-time neural recording at a fidelity and scale not previously possible.”

Next steps for Precision Neuroscience

Precision plans to follow the clearance with an expansion of its clinical research program. To date, the company reports testing the device in 37 patients through clinical study partnerships. It plans to announce more collaborations with leading research institutions later this year, having teamed up with Beth Israel Deaconess Medical Center (BIDMC) already in 2025. Other leading institutions include Mount Sinai Health System, the Perelman School of Medicine at the University of Pennsylvania, West Virginia University’s Rockefeller Neuroscience Institute.

The company states that implants, to date, have been limited to short durations. FDA clearance allows more extended deployments up to 30 days, for weeks at a time, instead of hours.

According to Rapaport, extended implant durations enhance the company’s ability to gather high-quality neural data. This can help improve the performance of its BCI systems, enabling them to work more effectively.

“In just four years since our founding, we’ve gone from an idea to achieving FDA clearance for our cutting-edge cortical array, which we manufacture in a facility that we own and operate,” said Michael Mager, Precision CEO and co-founder. “This is a testament to the extraordinary team we have attracted, and their ability to execute across multiple domains. Our mission is to deliver life-changing brain–computer interface technology to the millions of people who stand to benefit from it. This clearance represents a big step forward toward that goal.”