Layer 7 Cortical Interface
Precision Neuroscience's thin-film electrode array that rests on the surface of the brain. FDA 510(k) cleared (decision 30 March 2025) for temporary use of less than 30 days. Precision counted more than 100 patient procedures by September 2026 and targets early 2028 for the first implant of a permanent version.
Overview
Layer 7 is the core product of Precision Neuroscience. It is a thin, flexible film carrying up to 1,024 electrodes per array that conforms to the surface of the brain without penetrating tissue and can be removed. In a May 2024 procedure at Mount Sinai, surgeons placed four arrays together for a total of 4,096 electrodes. It records the same kind of surface signal as conventional ECoG grids, at much higher electrode density.
Regulatory status and use
The FDA cleared the device, as Layer 7-T, under 510(k) on 30 March 2025 for recording, monitoring and stimulating electrical activity on the brain’s surface for temporary use of less than 30 days. The clearance does not cover permanent implantation. Surgeons place the array in patients already undergoing operations such as tumour removal or epilepsy monitoring, and it is removed at the bedside before they go home. Patients without paralysis have used it in hospital to move cursors and play games such as Pong and Mario Kart.
Precision counted more than 100 patient procedures across 18 medical institutions by September 2026. An October 2026 preprint, which has not been peer reviewed, built an atlas of the human nervous system from the first 70 patients, drawing on more than 100,000 electrode placements across motor, sensory, language and auditory cortex, the brainstem and the spinal cord.
Why it matters
The temporary clearance gives Precision clinical volume and a growing data asset before any chronic product exists. The commercial case for people with paralysis depends on the permanent version, whose first implant is targeted for the beginning of 2028 and requires a separate FDA pathway. A $250 million Series D, closed in September 2026, is paying for that path.
Coverage on InsideBCI
- 9 October 2026: Precision Neuroscience posts a 70-patient map of the human nervous system
- 25 September 2026: Precision Neuroscience closes oversubscribed $250 million Series D co-led by Pershing Square and the Ackman Oxman Institute
- 21 July 2026: Precision Neuroscience demonstrates thought-based gaming in non-paralysed volunteers
- 8 April 2026: Precision Neuroscience’s Layer 7 Decodes Speech and Movement in First Peer-Reviewed Intraoperative Study