The Food and Drug Administration turned down a bid from Neuralink, the ambitious yet controversial human brain chip startup founded by America’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.
Key Facts
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.
Musk, Neuralink and the FDA did not immediately respond to emailed requests for comment.
Key Background
Neuralink, which seeks to assist neurologically and physically impaired people via its Bluetooth-enabled implants, has attracted criticism for the 1,500 animals, including monkeys, that have allegedly died in its experiments.
Founded by Musk in 2016, Neuralink has raised US$363 million since its inception, according to Crunchbase.
In addition to Musk, other notable investors in the company include Google’s investment arm GV, billionaire Coinbase cofounder Fred Ehrsam and Sam Altman, CEO of OpenAI, the company behind the generative artificial intelligence program ChatGPT.
Neuralink is one of Musk’s many ventures, as he is also the CEO and largest individual shareholder of SpaceX, Tesla and Twitter.
Forbes Valuation
Musk is worth US$185 billion, according to Forbes’ most recent estimates. His stake in Neuralink accounts for a small chunk of his wealth, a majority of which comes from his 13% stake in Tesla.
Tesla pain
Shares of Tesla sank 6% Thursday after Musk failed to impress investors at the electric vehicle company’s investor day event Wednesday.
This story was first published on forbes.com
