The Food and Drug Administration, which had initially rejected the application, finally gave the company the green light
Neuralink, Elon Musk’s brain-implant company, said on Thursday it had received a green light from the US Food and Drug Administration to kickstart its first in-human clinical study, a critical milestone after earlier struggles to gain approval.
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.
“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.
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