Precision Neuroscience's Layer 7 is a high-density electrocorticography (ECoG) array — a thin, flexible polyimide film containing 1,024 platinum electrodes that rests on the surface of the cortex without penetrating brain tissue. Each array is 1/5th the thickness of a human hair with 600x greater electrode density than standard cortical arrays. Placed subdurally via a minimally invasive cranial micro-slit (<1mm), the device is theoretically reversible. Multiple arrays can be combined — in June 2024 Precision set a world record by deploying 4,096 electrodes simultaneously. The array supports bidirectional recording and stimulation with adjustable parameters. FDA 510(k) clearance was granted in 2025 for temporary use (<30 days).
This device does not have a current FDA designation. It may be a research tool, preclinical device, or consumer product not subject to FDA medical device regulation.
FDA Device Regulatory Guidance ↗