BCI Atlas

Precision Neuroscience is pursuing a distinct engineering point in the BCI design space: high-channel-count cortical surface sensing with a thin, conformal film that can be placed on the brain surface rather than penetrating into cortex.

Their core device is the Layer 7 Cortical Interface — a high-density electrode array embedded in a flexible film intended for recording/monitoring (and, per their regulatory clearance/press coverage, stimulation) of cortical activity.

At a glance

• Website: https://precisionneuro.io/
• About page (company narrative + leadership): https://precisionneuro.io/about
• Headquarters: New York City (per press coverage; confirm on LinkedIn later if we want a consistent data source).

The technology: Layer 7 Cortical Interface

Public descriptions emphasize:

• Cortical surface interface (non-penetrating)
• Thin-film flexible array designed to conform to the brain surface
• High electrode count: commonly reported as 1,024 electrodes

Secondary reporting (MassDevice) describes the Layer 7 device as:

• 1,024 electrodes embedded in a flexible film

• thinness on the order of ~one-fifth the thickness of a human hair (journalistic paraphrase of company claims)

• MassDevice (Apr 17, 2025): https://www.massdevice.com/precision-neuroscience-fda-clearance-bci-interface/

Precision’s own framing is explicit about the design goal:

“a high-bandwidth connection to the brain that did not rely on penetrating electrodes”

• Precision “About”: https://precisionneuro.io/about

Regulatory status (key differentiator)

Precision reports that it received an FDA 510(k) clearance in 2025 for the Layer 7 Cortical Interface.

• Precision “About” (mentions first FDA clearance in 2025): https://precisionneuro.io/about

Multiple outlets report this as FDA 510(k) clearance and note a commercially-cleared use case window up to 30 days implantation.

• Press release (GlobeNewswire, Apr 17, 2025): https://www.globenewswire.com/news-release/2025/04/17/3063418/0/en/Precision-Neuroscience-Receives-FDA-Clearance-for-High-Resolution-Cortical-Electrode-Array.html
• MassDevice coverage (Apr 17, 2025): https://www.massdevice.com/precision-neuroscience-fda-clearance-bci-interface/

Primary regulatory document (510(k) letter/summary PDF):

• FDA 510(k) document (K242618): https://www.accessdata.fda.gov/cdrh_docs/pdf24/K242618.pdf

Why this approach is interesting (and what to watch)

1) Minimally invasive doesn’t mean “easy,” but it changes the risk profile

A surface array avoids penetrating tissue and may reduce certain risks (e.g., insertion trauma), but it still lives in a surgical environment with constraints around stability, infection, and long-term biocompatibility.

2) Surface recordings: bandwidth vs spatial specificity

High-density surface electrodes can offer rich signals, but the spatial selectivity differs from intracortical spikes. This makes algorithm+hardware co-design central: what do you decode, from which signal features, under what motion/noise conditions?

3) Clinical workflow matters

One of the more practical near-term wedges is intraoperative mapping (explicitly mentioned in reporting). That path pressures the system to be useful quickly, with neurosurgical-friendly setup time, robust connectors, and clean data plumbing.

• MassDevice notes intraoperative mapping as a clinical marketing path post-clearance: https://www.massdevice.com/precision-neuroscience-fda-clearance-bci-interface/

4) “Removable” and “up to 30 days” are big claims — watch the details

A surface interface that is both high-density and safely removable (and has a cleared temporary implant window) is a meaningful engineering milestone. The details that will matter:

• what the cleared indications actually are
• what “up to 30 days” means in practice (patient selection, monitoring, adverse event profile)
• signal quality drift over days/weeks

Primary reference for the clearance details:

• FDA K242618 document: https://www.accessdata.fda.gov/cdrh_docs/pdf24/K242618.pdf

Company notes (from Precision)

Precision’s own history highlights:

• founded/started work in 2021

• leadership includes co-founder Ben Rapoport (MD, PhD)

• claims of owning/operating manufacturing capacity via acquiring a microfabrication facility (Precision BioMEMS)

• FDA Breakthrough Designation (2023) and FDA 510(k) Clearance (2025)

• Precision “About”: https://precisionneuro.io/about

Notes on sourcing

• For the core “what is it” and “why this design,” I rely on Precision’s own About page.
• For regulatory status and numerical claims (electrode count, 30-day clearance window), I cite secondary coverage plus the primary FDA 510(k) PDF.