Devices

A thin-film cortical electrode array with 1,024 electrodes from Precision Neuroscience. FDA 510(k) clearance announced 17 April 2025 for implantation up to 30 days, as a component of a wireless BCI still in development.

Device — Cortical surface

Precision Layer 7 Cortical Interface

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Precision Neuroscience · Layer 7 · thin film · ECoG · FDA 510(k) · cortical surface · human · company

Precision Layer 7 Cortical Interface

One-line verdict: A surface array with penetrating-array channel counts. It is cleared for temporary use now, and the permanent wireless system it belongs to is not yet in the clinic.

Quick tags: Recording and stimulation · Cortical surface · Human · Announced April 2025

Overview

What it is: The Layer 7 Cortical Interface, a high-resolution cortical electrode array for recording, monitoring and stimulating electrical activity on the surface of the brain. Trade and device name on the FDA record is Layer 7-T.

Form: MassDevice reports a thin-film design with 1,024 electrodes embedded in a flexible film that conforms to the brain surface, at one-fifth the thickness of a human hair.

Regulatory status: Precision announced 510(k) clearance on 17 April 2025. The company says the array is authorized for commercial use with implantation durations of up to 30 days, and that it is a core component of a fully implantable, wireless BCI system still in development. The FDA lists it as a Class II cortical electrode (510(k) K242618, regulation 21 CFR 882.1310).

What it is not yet: A permanent implant. The 30-day limit applies to the cleared array, not to the future wireless system.

Spec Card Grid

Identity

  • Company: Precision Neuroscience Corporation
  • FDA record: K242618, Layer 7-T, Class II, product code GYC
  • Announced: 17 April 2025

Architecture

  • Electrodes: 1,024, thin film
  • Placement: brain surface
  • Cleared implantation duration: up to 30 days
  • Film thickness and area: only the one-fifth-of-a-hair comparison is published in the sources used here

Evidence and limits

  • No 3D model yet: array area and electrode pitch are not in the sources used here

References