Neurotech startup Precision Neuroscience announced that a core component of its brain implant system has been approved by the Food and Drug Administration (FDA) on Thursday.
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.
While only part of the brain implant system was cleared, it is still an important milestone for the four-year-old company as it marks the first full regulatory clearance granted to a company developing a wireless BCI.
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“This is a foundational moment for Precision,” Precision co-founder and Chief Science Officer Benjamin Rapoport said in a release. “By introducing the Layer 7 Cortical Interface into clinical settings, we’ll be able to deliver immediate value for patients and neurosurgical teams, enabling real-time neural recording at a fidelity and scale not previously possible.”
Precision also revealed that this would be followed by an expansion of its clinical research program with the company having tested its device in 37 patients to date through clinical study partnerships with leading research institutions including Mount Sinai Health System, the Perelman School of Medicine at the University of Pennsylvania, West Virginia University’s Rockefeller Neuroscience Institute, and Beth Israel Deaconess Medical Center.
Other prominent companies working in this space include Elon Musk’s Neuralink and Synchron, which is backed by Amazon founder Jeff Bezos and Microsoft co-founder Bill Gates. Rapoport had also helped co-found Musk’s Neuralink in 2017, and left the company the following year.
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The piece of Precision’s system that the FDA approved is called the Layer 7 Cortical Interface. The microelectrode array is thinner than a human hair and resembles a piece of yellow scotch tape. Each array is made up of 1,024 electrodes that can record, monitor and stimulate electrical activity on the brain’s surface.
When it is placed on the brain, Precision says it can conform to the surface without damaging any tissue. The FDA-authorized Layer 7 is to be implanted in patients for up to 30 days, and Precision will be able to market the technology for use in clinical settings.