(Bloomberg) -- A brain-computer interface company is entering clinical trials for its implants in the U.S., a big step toward getting the futuristic devices into more skulls to help treat conditions like paralysis.
New York-based Synchron Inc. said it received permission from the Food and Drug Administration to test its device in human patients. The trial, known as an early feasibility study, is essential to proving the implants work safely and could one day be sold in the U.S.
Synchron beat other companies—including Elon Musk’s Neuralink—to announcing that it had secured regulatory approval for tests of a commercial product in human heads. “Commercial is another way to say practical, and applicable to real life,” said Dr. J Mocco, the chief medical officer at Synchron and a professor of neurosurgery at Mount Sinai Health System in New York.
Commercial brain-computer interfaces are a relatively new area for the FDA. The agency plans to hold a webinar on Thursday, when it will provide further guidance on topics such as how to design appropriate clinical trials.