The Food and Drug Administration (FDA) turned down a bid from Neuralink, the human brain chip startup founded by Elon Musk, to begin human trials, Reuters reported Thursday.
In explaining the decision to Neuralink, the agency outlined dozens of issues the company must address before human testing, a critical milestone on the path to final product approval, seven current and former employees told Reuters.
The agency’s major safety concerns involved the device’s lithium battery; the potential for the implant’s tiny wires to migrate to other areas of the brain; and questions over whether and how the device can be removed without damaging brain tissue, the employees said.
The Neuralink sources declined to provide Reuters with the agency’s written rejection, a legally confidential document. The staffers, including four who had read the FDA document and others aware of the agency’s concerns, described the safety issues in interviews, speaking on condition of anonymity.
Rejection a setback for Elon Musk’s Neuralink
The decision is 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.
In public comments over the years, Musk has detailed a bold vision for Neuralink: both disabled and healthy people will pop into neighborhood facilities for speedy surgical insertions of devices with functions ranging from curing obesity, autism, depression or schizophrenia to web-surfing and telepathy.
Eventually, Musk has said, such chips will turn humans into cyborgs who can fend off the threat from sentient machines powered by artificial intelligence.
“I could have a Neuralink device implanted right now, and you wouldn’t even know,” Musk said recently.
CNBC reports that at a public company event in 2020, he said: “You’ll be able to save and replay memories…. The future is going to be weird.”
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 $363 million since its inception, according to Crunchbase.
Bloomberg reports that in addition to Musk, other notable investors in the company include Google’s investment arm GV, billionaire Coinbase co-founder 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.