Regulators in the United States have given approval to Elon Musk’s start-up Neuralink to test its brain implants on humans.
Neuralink said Thursday it has received approval from the US Food and Drug Administration (FDA) for the first human clinical trial of implants intended to allow the brain to communicate directly with computers.
“We are pleased to announce that we have received FDA approval to begin our first human clinical trial,” Musk-owned Neuralink said in a post on Twitter.
Neuralink prototypes, which are the size of a coin, have so far been implanted in the skulls of monkeys, the startup’s demonstrations showed.
Using a surgical robot, a piece of the skull is replaced with a Neuralink disk and the wispy wires are strategically inserted into the brain, an early demonstration showed.
The drive records nerve activity and relays the information via a common Bluetooth wireless signal to a device such as a smartphone, Musk said.
“It actually fits in your skull quite nicely,” Musk said during an earlier presentation.
“It could be under your hair and you wouldn’t know it.”
Congratulations Neuralink team! https://t.co/AWZGf33UDr
— Elon Musk (@elonmusk) May 26, 2023
In an earlier presentation, Neuralink showed several monkeys “playing” simple video games or moving a cursor on a screen through their Neuralink implant.
The technology has also been tested in pigs.
Recruitment for a human clinical trial is not yet open, according to Neuralink.
Musk, who recently founded a company dedicated to developing advanced artificial intelligence, has argued that syncing minds with machines is vital if humans are to avoid being outdone by AI.
Experts and academics remain wary of his view of symbiotically fusing minds with super-powered computers.
‘As amazing as it may sound’
Since 2019, Musk predicted at least four times that his medical device company would soon begin human trials of a brain implant to treat persistent conditions such as paralysis and blindness. Yet the company, founded in 2016, didn’t seek FDA approval until early 2022 — and the agency rejected the application, seven current and former employees told Reuters news agency in March.
The FDA’s approval comes after US lawmakers earlier this month urged regulators to investigate whether the composition of a panel overseeing animal testing at Neuralink contributed to botched and hasty experiments. Neuralink has already been the subject of federal probes.
Reuters reported in December 2022 that the inspector general of the United States Department of Agriculture (USDA) was investigating possible violations of the Animal Welfare Act, which governs how researchers treat and test certain types of animals, at the request of a federal prosecutor. The probe also looked at the USDA’s oversight of Neuralink.
Musk has said that Neruralink would try to use the implants to restore vision and mobility in people who had lost such abilities.
“We would initially enable someone who is almost unable to operate their muscles … and enable them to operate their phone faster than someone with working hands,” he said.
“As miraculous as it may sound, we believe it is possible to restore full body functionality to someone with a spinal cord transection,” he said.
Other companies working on similar systems include Synchron, which announced in July that it had implanted the first human brain-machine interface in the United States.
Members of the Neuralink team have shared a “wish list” that ranged from technology that returns mobility to the paralyzed and vision to the blind, to enabling telepathy and uploading memories for later reference – or perhaps downloading into replacement bodies.