U.S. regulators rejected Elon Musk’s bid to test brain chips in humans, citing safety risks

March 04, 2023

Companies that do secure human-testing approval typically conduct at least two rounds of trials before applying for FDA approval to commercially market a device. "Everybody in the industry was saying: 'Oh my God, they're going to run straight into a brick wall,'" Ludwig said of Musk's bid for FDA approval. For example, NeuroPace, which makes the brain implant to treat epilepsy, received final FDA approval in 2013 – 16 years after the company's launch. Beyond grants, it provides access to government experts who advise on how to gain FDA approval and commercialize a device. Musk's emails to Neuralink staffers often come from his SpaceX address, said two people who reviewed them.