Neuralink said on Thursday that it received clearance from the US Food and Drug Administration (FDA) for the first human clinical study of implants which are intended to let the brain interface directly with computers.

“We are excited to share that we have received the FDA’s approval to launch our first-in-human clinical study,” Neuralink said in a post on Twitter – which is owned by Musk.

Neuralink prototypes, which are the size of a coin, have so far been implanted in the skulls of monkeys, demonstrations by the startup showed.

With the help of a surgical robot, a piece of the skull is replaced with a Neuralink disk, and its wispy wires are strategically inserted into the brain, an early demonstration showed.

The disk registers nerve activity, relaying the information via a common Bluetooth wireless signal to a device such as a smartphone, according to Musk.

“It actually fits quite nicely in your skull,” Musk said during a prior presentation.

“It could be under your hair and you wouldn’t know.”

Congratulations Neuralink team! https://t.co/AWZGf33UDr

— Elon Musk (@elonmusk) May 26, 2023

At a previous presentation, Neuralink showed several monkeys “playing” basic video games or moving a cursor on a screen through their Neuralink implant.

The technology has also been tested in pigs.

Recruitment for a clinical trial with humans is not yet open, according to Neuralink.

Musk, who recently established a business devoted to developing sophisticated artificial intelligence, has contended that synching minds with machines is vital if people are going to avoid being outpaced by AI.

Experts and academics remain cautious about his vision of symbiotically merging minds with super-powered computing.

‘As miraculous as it may sound’

On at least four occasions since 2019, Musk predicted that his medical device company would soon start human trials of a brain implant to treat intractable conditions such as paralysis and blindness. Yet the company, founded in 2016, did not seek permission from the FDA until early 2022 – and the agency rejected the application, seven current and former employees told the Reuters news agency in March.

The FDA’s approval comes as US legislators urged regulators earlier this month to investigate whether the makeup of a panel overseeing animal testing at Neuralink contributed to botched and rushed experiments. Neuralink has already been the subject of federal probes.

Reuters reported in December 2022 that the US Department of Agriculture’s (USDA) inspector general was investigating, at the request of a federal prosecutor, potential violations of the Animal Welfare Act, which governs how researchers treat and test certain types of animals. The probe has also been looking at the USDA’s oversight of Neuralink.

Musk has said that Neruralink would try to use the implants to restore vision and mobility in humans who had lost such abilities.

“We would initially enable someone who has almost no ability to operate their muscles … and enable them to operate their phone faster than someone who has working hands,” he said.

“As miraculous as it may sound, we are confident that it is possible to restore full body functionality to someone who has a severed spinal cord,” 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 returning mobility to the paralysed and sight to the blind, to enabling telepathy and the uploading of memories for later reference – or perhaps to be downloaded into replacement bodies.