Precision Neuroscience's Layer 7 is a high-density electrocorticography (ECoG) array — a thin, flexible film containing 1,024 electrodes that rests on the surface of the cortex without penetrating brain tissue. Unlike intracortical approaches, Layer 7 is placed subdurally via a minimally invasive slit craniotomy. Because the electrodes sit on the cortical surface rather than piercing it, the device is theoretically reversible and associated with a lower inflammatory response than penetrating arrays. The PATTERN I trial conducts acute intraoperative recordings during elective neurosurgical procedures to validate signal quality and safety. Precision was co-founded by former Neuralink engineers Benjamin Rapoport and Vindum Vedam-Mai.
An IDE permits a device to be used in a clinical study to collect safety and effectiveness data required for a PMA or 510(k) submission. IDE devices are not approved for commercial sale.
FDA Device Regulatory Guidance ↗