by Sean Whooley for Mass Device

Precision Neuroscience announced today that its brain-computer interface (BCI) technology won FDA breakthrough device designation.

The company also acquired a microelectromechanical systems (MEMS) foundry outside Dallas, Texas. Completed through its Precision BioMEMS subsidiary, the acquisition brings its supply chain in-house. It also establishes Precision as a leading-edge manufacturer of biomedical MEMS in the U.S., according to a news release.

Precision Neuroscience develops the Layer 7 Cortical Interface, designed with 1,024 tiny electrodes spanning an area of one square centimeter. The company embedded the electrodes in a flexible film that conforms to the brain surface. This film — one-fifth the thickness of a human hair — is designed for implantation and removal by neurosurgeons without damaging brain tissue.

The company designed it to map a large area of the brain’s surface at resolutions higher than typical neurosurgical procedures. Founded in 2021, Precision Neuroscience began the first-in-human pilot clinical study for the implant in June of this year.

Benjamin Rapoport, a founding member of Elon Musk’s Neuralink BCI venture, started the company with private equity investor Michael Mager. Mager serves as CEO of Precision Neuroscience.

The Precision Neuroscience BCI remains investigational and not for sale in the U.S. According to a CNBC report, the company has its eyes on regulatory approval in 2024.

Precision Neuroscience says it expects its brain implant to enable people with severe neurological conditions, like speech deficits and paralysis, to regain independence, communicate with loved ones and rejoin the workforce…”

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