Elon Musk’s brain-implant company Neuralink has announced that its first-in-human clinical trial has been approved by the US Food and Drug Administration (FDA).
The FDA approval “represents an important first step that will one day allow our technology to help many people,” according to a tweet from Neuralink.
It did not elaborate on the study’s objectives, just stating that it was not yet recruiting and that further information would be forthcoming soon.
Musk envisions brain implants could cure a range of conditions including obesity, autism, depression and schizophrenia as well as enabling web browsing and telepathy.
He made headlines late last year when he declared he was so sure the gadgets were safe that he would implant them in his children.
Musk has forecast that Neuralink will commence human testing at least four times since 2019. However, the corporation only applied for FDA permission in early 2022, and the agency denied the application.
We are excited to share that we have received the FDA’s approval to launch our first-in-human clinical study!
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…
— Neuralink (@neuralink) May 25, 2023
The FDA had pointed out several concerns to Neuralink that needed to be addressed before sanctioning human trials, according to the employees.
Major issues involved the lithium battery of the device, the possibility of the implant’s wires migrating within the brain, and the challenge of safely extracting the device without damaging brain tissue.
Neuralink, founded in 2016, has been the subject of several federal probes.
U.S. lawmakers in May urged regulators to investigate whether the makeup of a panel overseeing animal testing at Neuralink contributed to botched and rushed experiments.
The Department of Transportation is separately probing whether Neuralink illegally transported dangerous pathogens on chips removed from monkey brains without proper containment measures.
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