April 20, 2025 - Precision Neuroscience has achieved a landmark regulatory milestone with the U.S. Food and Drug Administration (FDA) granting 510(k) clearance for its Layer 7 Cortical Interface, a next-generation brain-computer interface (BCI) system designed to restore function in patients with neurological impairments.
The Layer 7 Cortical Interface is a minimally invasive, ultra-thin electrode array featuring 1,024 microelectrodes on a flexible film one-fifth the thickness of a human hair. This design allows the device to conform seamlessly to the brain’s surface without penetrating tissue or causing damage, enabling high-resolution recording and stimulation of neural activity. Unlike traditional implants, it can be inserted through a tiny “micro-slit” incision less than 1mm thick, reducing surgical risks and facilitating reversibility.
Significantly, the FDA clearance authorizes the device to remain implanted for up to 30 days, a major extension from prior intraoperative uses lasting only minutes or hours. This duration enables extended neural data collection critical for refining AI-driven neural decoding algorithms that translate brain signals into digital commands, potentially restoring speech, movement, and independence to patients with paralysis or other neurological conditions.
Precision Neuroscience has already tested the Layer 7 interface in over 35 patients across leading institutions including Mount Sinai, University of Pennsylvania, WVU Rockefeller Neuroscience Institute, and Beth Israel Deaconess Medical Center, demonstrating safety and efficacy.
The company plans to expand clinical research and commercialize the technology for intraoperative brain mapping and other diagnostic applications, generating near-term revenue while advancing toward long-term therapeutic goals.
Benjamin Rapoport, MD, PhD, Chief Science Officer and Co-Founder, emphasized the importance of this clearance: “By enabling extended implant durations, we exponentially increase access to high-quality neural data essential for building brain-computer interface systems that work more effectively.” CEO Michael Mager highlighted the four-year journey from concept to clearance as a testament to the company’s innovation and agility.
This FDA milestone positions Precision Neuroscience as a formidable rival to Elon Musk’s Neuralink, offering a safer, reversible, and scalable BCI platform with unprecedented electrode density and implantation ease. The breakthrough opens new horizons for neurotechnology, promising to transform neurological care and empower millions living with disabling brain injuries and diseases.
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For more information, visit Precision Neuroscience’s official communications and recent clinical publications.
