Precision Neuroscience has announced that its high-resolution cortical electrode array, the Layer 7 Cortical Interface, has been granted 510(k) clearance by the US Food and Drug Administration (FDA).
This regulatory approval allows for the device’s use in recording, monitoring, and stimulating electrical activity on the brain’s surface, with implantation permitted for up to 30 days.
The Layer 7 Cortical Interface is integral to Precision Neuroscience’s fully implantable, wireless brain–computer interface system currently in development.
The FDA clearance marks the first full regulatory approval for a next-generation wireless brain-computer interface (BCI) company, enabling Precision Neuroscience to market its technology for clinical applications such as intraoperative brain mapping.
Precision Neuroscience chief science officer and co-founder Benjamin Rapoport said: “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.”
Following this regulatory achievement, Precision Neuroscience plans to expand its clinical research programme. To date, the company has tested the device in 37 patients through collaborations with various research institutions, including Mount Sinai Health System and the Perelman School of Medicine at the University of Pennsylvania.
Current implants have been limited to short procedures, but the new clearance allows deployments for up to 30 days, enhancing potential scientific discoveries, said the company.
Precision Neuroscience CEO and co-founder Michael Mager said: “In just four years since our founding, we’ve achieved FDA clearance for our cortical array. This success underscores our team’s capability across multiple domains and furthers our mission to deliver transformative BCI technology.”
Earlier in February 2025, Precision Neuroscience announced a research collaboration with Beth Israel Deaconess Medical Center (BIDMC), affiliated with Harvard Medical School.
The initiative aims to enhance understanding of brain functions during craniotomy procedures using Precision Neuroscience’s Layer 7 Cortical Interface. The device features 1,024 ultra-thin electrodes across a flexible film designed to capture neural activity with exceptional detail.
