Elon Musk’s Neuralink Faces New FDA-Approved Rival In Precision Neuroscience

A Neuralink rival backed by a former collaborator of Elon Musk has just received FDA clearance for its brain implant.

Precision Neuroscience, a fast-growing startup developing brain-computer interface (BCI) technology, announced on Thursday that it has received clearance from the U.S. Food and Drug Administration to market a key component of its implant system for clinical use. 

The approval signals an increase in competition in the neurotech space, where Elon Musk’s Neuralink has drawn significant public and regulatory attention.

The device, known as the Layer 7 Cortical Interface, is a thin, flexible microelectrode array designed to record and stimulate neural activity without penetrating brain tissue. 

The FDA has cleared it for clinical use in procedures lasting up to 30 days, allowing surgeons to temporarily implant the array to map brain activity. 

While not the company’s end-use goal, the clearance enables Precision to generate near-term revenue and gather valuable real-world data.

Brain-computer interfaces, or BCIs, are designed to translate neural signals into digital commands to power external devices. 

Precision’s initial focus is on patients with severe paralysis, helping to restore lost functions such as movement and speech. 

“Neural decoding algorithms, like all AI-driven products, rely on vast amounts of data,” said Rapoport, Precision’s Chief Science Officer. “This regulatory clearance will exponentially increase our access to high-quality data, which will help us build BCI systems that work more effectively.”

The Layer 7 device contains 1,024 electrodes packed onto a film thinner than a human hair. It conforms to the brain’s surface, avoiding the need to pierce neural tissue, unlike traditional deep brain stimulation systems used by companies such as Medtronic.

The FDA’s decision places Precision in closer competition with Neuralink, which is currently conducting human trials for its implantable device. Other players in the space include Synchron, backed by Amazon’s (AMZN) Jeff Bezos and Microsoft’s (MSFT) Bill Gates.

The approval comes at a time when the broader AI and medical device stocks face pressure.

The Global X Robotics & Artificial Intelligence ETF (BOTZ), which tracks companies involved in automation and AI, has fallen 17% this year, while the iShares U.S. Medical Devices ETF (IHI) is down 2.5% amid President Donald Trump’s sweeping tariffs, global policy uncertainty, and tighter regulatory scrutiny. 

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