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Musk's Neuralink 'cleared' for human test of brain implants

Neuralink says clearance from US Food and Drug Administration for its first in-human clinical study is "an important first step" for its technology, which is intended to let brains interface directly with computers.

AFP

Neuralink is developing a brain implant it hopes will help paralysed people walk again and cure other neurological ailments. / Photo: AFP

Elon Musk's start-up Neuralink has said it has received approval from the US regulators to test its brain implants in people.

Neuralink said clearance on Thursday from the US Food and Drug Administration [FDA] for its first-in-human clinical study is "an important first step" for its technology, which is intended to let brains 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 Musk-run Twitter. "This is the result of incredible work by the Neuralink team in close collaboration with the FDA."

On at least four occasions since 2019, Musk has 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 approval comes as US lawmakers urged regulators earlier this month to investigate whether the make-up of a panel overseeing animal testing at Neuralink contributed to botched and rushed experiments.

"This is the result of incredible work by the Neuralink team in close collaboration with the FDA and represents an important first step that will one day allow our technology to help many people," Neuralink said in a tweet on Thursday.

Elon Musk expects Neuralink to begin human trials in six months

Federal probes

Neuralink has already been the subject of federal probes.

Reuters reported on December 5 that the USDA's 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.

Neuralink is developing a brain implant it hopes will help paralysed people walk again and cure other neurological ailments.