FDA Approves New Brain Computer Interface Implant

The FDA has approved a new brain computer interface implant.

In a press release, Precision Neuroscience announced that the FDA has approved a major part of its brain implant system.

Precision is a neurotech startup that is building a brain-computer interface (BCI) to assist patients with paralysis in movements and speech.

Precision Neuroscience is a competitor to Elon Musk’s BCI company, Neuralink.

The Food and Drug Administration on Thursday approved a core component of a brain implant made by Precision Neuroscience. https://t.co/M9kIk8fkZo https://t.co/M9kIk8fkZo

— Forbes (@Forbes) April 17, 2025

A rival to Elon Musk's Neuralink has received FDA clearance for a brain device it says is less invasive https://t.co/kI516O6Rnj

— Bloomberg (@business) April 17, 2025

Here’s how a BCI works:

👀 Neuralink Recipient Noland Arbaugh on How the Implant Has Changed His Life & the Potential It Offers

"When I moved [the computer cursor] for the first time with my mind without attempting to move at all, I was giddy the entire day. I couldn't believe what had just happened."… pic.twitter.com/xsg4J3lcfw

— Chief Nerd (@TheChiefNerd) June 20, 2024

Here’s what CNBC reported:

Neurotech startup Precision Neuroscience on Thursday announced that a core component of its brain implant system has been approved by the U.S. Food and Drug Administration, a major win for the four-year-old company.

Precision is building a brain-computer interface, or a BCI, which is a system that decodes neural signals and translates them into commands for external technologies. The company’s BCI will initially be used to help patients with severe paralysis restore functions such as speech and movement, according to its website.

Only part of Precision’s system was approved by the FDA on Thursday, but it marks the first full regulatory clearance granted to a company developing a wireless BCI, Precision said in a release. Other prominent startups in the space include Elon Musk’s Neuralink, and Synchron, which is backed by Amazon founder Jeff Bezos and Microsoft
co-founder Bill Gates.

“This is a foundational moment for Precision,” Dr. Benjamin Rapoport, Precision’s co-founder and chief science officer, said in a statement. Rapoport also helped co-found Musk’s Neuralink in 2017 before departing the following year.

Neuralink has released a new video with Nolan, its first human recipient of its brain chip. pic.twitter.com/SWbQ2dulLv

— Sawyer Merritt (@SawyerMerritt) May 16, 2024

Per Quartz:

Elon Musk’s Neuralink has been a trailblazer in brain chip implant technology. But today, rival company Precision Neuroscience announced that a core component of its brain implant system has been approved by the U.S. Food and Drug Administration.

The Precision Neuroscience website describes a Layer 7 Cortical Interface as: A thin film microelectrode array that is engineered to conform to the brain’s cortex without damaging tissue.

The array is a core component of Precision’s fully implantable, wireless, brain–computer interface system, which is currently in development. With this clearance, the Layer 7 Cortical Interface is now authorized for commercial use with implantation durations of up to 30 days.