Neuralink rival gets FDA clearance for its brain implant

Neuralink rival gets FDA clearance for its brain implant
18 Apr 2025

Leading neurotechnology start-up Precision Neuroscience has secured the approval of the US Food and Drug Administration (FDA), for a critical part of its brain implant system.

The groundbreaking technology will decode neural signals and convert them into commands for external devices.

The main aim of this brain-computer interface (BCI) is to help patients with severe paralysis regain critical functions like speech and movement, according to the company's website.

Other prominent start-ups working on BCIs are Neuralink and Synchron.

First regulatory approval for wireless brain-computer interface
Milestone achievement

The FDA's approval is a major milestone in the field of neurotechnology, it being the first full regulatory clearance given to a company working on a core component of a wireless BCI.

Precision Neuroscience's co-founder and Chief Science Officer, Dr. Benjamin Rapoport, called this "a foundational moment for Precision."

Rapoport also helped found Elon Musk's Neuralink in 2017 before leaving the next year.

Layer 7 Cortical Interface: A closer look
Technology details

The FDA-approved component is called the Layer 7 Cortical Interface. It features a microelectrode array thinner than a human hair and looks like yellow scotch tape.

Each array features 1,024 electrodes that can record, monitor, and stimulate electrical activity on the brain's surface without harming any tissue.

The FDA has approved the device for implantation in patients for as long as 30 days.

FDA approval opens new avenues for data collection
Future prospects

With the FDA's approval, Precision Neuroscience can now market the Layer 7 Cortical Interface for clinical use.

This will enable surgeons to use the array during surgeries to map brain signals, bringing in revenue for the company in the short term.

So far, Precision has temporarily implanted Layer 7 in 37 patients and plans to use this regulatory clearance to collect long-term data.

"This regulatory clearance will exponentially increase our access to diverse, high-quality data," Rapoport stated.