Elon Musk's brain-implant company Neuralink on Thursday said it had received the US Food and Drug Administration's approval to launch its first in-human clinical study.
At least four times since 2019, Mr 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.
But the company, founded in 2016, did not seek permission from the FDA until early 2022 – and the agency rejected the application, current and former employees told Reuters in March.
The FDA approval comes as US legislators urged regulators this month to investigate whether the make-up of a panel overseeing animal testing at Neuralink contributed to botched and rushed experiments.
Neuralink has already been the subject of federal investigations.
The US Department of Agriculture's inspector general was late last year investigating, at the request of a federal prosecutor, possible breaches of the Animal Welfare Act, which governs how researchers treat and test certain types of animals.
The inquiry has also been looking at the USDA's regulation of Neuralink.
In a tweet on Thursday, Neuralink said that the company was not yet open for a clinical trial.
"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," the company said in a tweet on Thursday.
Neuralink is developing a brain implant it hopes will help paralysed people to walk again and cure other neurological ailments.
The FDA did not immediately respond to a request for comment.