The Food and Drug Administration turned down a bid from Neuralink, the ambitious yet controversial human brain chip startup founded by the nation’s richest man Elon Musk, to begin human trials, Reuters reported Thursday, a major setback for the ambitious yet controversial startup even as Musk claims Neuralink’s implants are safe enough for insertion into his and children’s brains.
The U.S. agency overseeing clinical trials denied Neuralink’s request to begin human testing early last year, seven current and former Neuralink employees shared with Reuters.
It’s a surprising revelation considering Musk said last November that human testing for Neuralink could happen as soon as May 2023.
Neuralink is now almost certain to miss its own target date for FDA approval of March 7, 2023, which it set last year, Reuters reported, with sources telling the outlet it’s a “gamble” to set any target date to begin human trials given the regulatory pushback.