Precision Neuroscience receives FDA clearance for brain implant

Precision Neuroscience announced it has received 510(k) clearance from the FDA for its Layer 7 Cortical Interface, a thin, flexible electrode array designed to rest on the brain’s surface and remain implanted for up to 30 days. This milestone positions the New York-based startup, founded in 2021 by Benjamin Rapoport, a Neuralink co-founder, as a key contender in the race to develop brain-computer interfaces (BCIs), alongside rivals such as Elon Musk’s Neuralink and Synchron. The device enables high-resolution brain mapping and is intended for intraoperative use, such as guiding neurosurgeries or gathering data for BCI algorithm training. Precision Neuroscience has already tested the technology in 37 patients, primarily in short-term use cases during brain tumor surgeries.

With FDA clearance, the company can now commercially offer the device for short-term brain monitoring and begin accumulating valuable neural data to support the development of future assistive technologies, such as robotic limb control. CEO Michael Mager highlighted the company’s rapid progress since its founding, noting that the device is manufactured in-house. The approval sets Precision apart as the first next-generation wireless BCI developer to gain FDA clearance for such a device. While competitors like Neuralink and Synchron are also progressing with human trials, Precision’s new regulatory milestone allows it to move forward with both clinical and commercial applications in the growing field of neurotechnology.