NEW YORK, April 17, 2025 (GLOBE NEWSWIRE) -- Precision Neuroscience Corporation (Precision), a leader in brain–computer interface (BCI) technology, today announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the Layer 7 Cortical Interface, its high-resolution cortical electrode array, for use in the recording, monitoring, and stimulation of electrical activity on the surface of the brain. The array is a core component of Precision’s fully implantable, wireless brain–computer interface system, which is currently in development. With this clearance, the Layer 7 Cortical Interface is now authorized for commercial use with implantation durations of up to 30 days.
The clearance represents a major milestone for the brain–computer interface field, as it marks the first full regulatory clearance granted to a company developing a next-generation wireless BCI. It also paves the way for Precision to begin marketing its technology for clinical applications, such as intraoperative brain mapping. "This is a foundational moment for Precision," said Benjamin Rapoport, MD, PhD, 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."
Precision will follow the clearance with an expansion of its clinical research program. The company has tested its device in 37 patients to date through clinical study partnerships with leading research institutions, including Mount Sinai Health System, the Perelman School of Medicine at the University of Pennsylvania, West Virginia University's Rockefeller Neuroscience Institute, and Beth Israel Deaconess Medical Center. Additional collaborations will be announced later this year. These implants have, until now, been limited to short durations during neurosurgical procedures. This clearance allows Precision’s technology to be deployed for longer durations, up to 30 days—for weeks at a time, instead of hours––opening up new possibilities for scientific discovery.
Rapoport emphasized that extended implant durations will enhance Precision’s ability to gather high-quality neural data, which is essential for improving the performance of its brain–computer interface systems. “Neural decoding algorithms, like all AI-driven products, rely on vast amounts of data,” he said. “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.”
Michael Mager, Precision's CEO and Co-Founder, reflected on Precision's evolution from a startup to a clinical-grade medical technology company: "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. 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."
About Precision Neuroscience
Precision Neuroscience is working to provide breakthrough treatments for the millions of people worldwide suffering from neurological illness. The company is building the only brain–computer interface designed to be minimally invasive, safely removable, and capable of processing large volumes of data. To learn more about how Precision is connecting human intelligence and artificial intelligence, visit www.precisionneuro.io.
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