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.
“This is a foundational moment for Precision,” the company’s co-founder and chief science officer, Benjamin Rapoport, said in a statement. “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.”
Going forward, Precision said it plans to expand its research program, which to date has tested its device in 37 patients, largely in short durations during neurosurgical procedures. The company raised $104 million in venture capital funding last December—through a series C round led by General Equity Holdings, with additional backing from B Capital, Steadview Capital and Duquesne Family Office, the investment firm of Stanley F. Druckenmiller.
The company also recently announced a clinical research project with Beth Israel Deaconess Medical Center aimed at craniotomy procedures and epilepsy surgery, and recording how the brain governs complex behaviors.
“Neural decoding algorithms, like all AI-driven products, rely on vast amounts of data,” Rapoport added. “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.”
Precision was founded in 2021, with Rapoport previously serving as a founding member of Elon Musk’s Neuralink.
“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 co-founder and CEO Michael Mager. “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.”