Precision Neuroscience Corporation announced today that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Layer 7 Cortical Interface, a high-resolution electrode array designed for recording, monitoring, and stimulating electrical activity on the brain's surface. This regulatory milestone represents the first full clearance granted to a company developing next-generation wireless brain-computer interface (BCI) technology.
The Layer 7 Cortical Interface serves as a core component of Precision's fully implantable, wireless BCI system currently under development. With this clearance, the device is now authorized for commercial use with implantation durations extending up to 30 days.
"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."
Extended Implantation Enables Advanced Neural Data Collection
Prior to this clearance, Precision's clinical studies were limited to short-duration implantations during neurosurgical procedures. The new authorization for up to 30-day implantations represents a significant advancement, allowing researchers to collect neural data over weeks rather than hours.
Rapoport emphasized the critical importance of extended data collection periods: "Neural decoding algorithms, like all AI-driven products, rely on vast amounts of data. 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."
The company has already tested its device in 37 patients through clinical study partnerships with leading research institutions, including:
- Mount Sinai Health System
- Perelman School of Medicine at the University of Pennsylvania
- West Virginia University's Rockefeller Neuroscience Institute
- Beth Israel Deaconess Medical Center
Precision plans to announce additional research collaborations later this year as it expands its clinical program.
Immediate Clinical Applications
The FDA clearance paves the way for Precision to begin marketing its technology for clinical applications such as intraoperative brain mapping. This represents an important step toward commercialization while the company continues developing its complete BCI system.
Michael Mager, Precision's CEO and Co-Founder, reflected on the company's rapid progress: "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."
Advancing BCI Technology for Neurological Applications
Brain-computer interfaces represent a promising frontier in neurotechnology, with potential applications ranging from treating neurological disorders to restoring function in patients with paralysis. Precision's approach focuses on developing minimally invasive, safely removable interfaces capable of processing large volumes of neural data.
"Our mission is to deliver life-changing brain-computer interface technology to the millions of people who stand to benefit from it," Mager stated. "This clearance represents a big step forward toward that goal."
The Layer 7 Cortical Interface clearance positions Precision Neuroscience at the forefront of clinically viable BCI technology development, with a clear pathway toward expanded research capabilities and eventual therapeutic applications.
