Neuralink, Elon Musk’s brain-implant company, said on Thursday it had received a green light from the US Food and Drug Administration (FDA) to kickstart its first in-human clinical study, a critical milestone after earlier struggles to gain approval.
Musk has predicted on at least four occasions since 2019 that his medical device company would begin human trials for a brain implant to treat severe conditions such as paralysis and blindness.
Yet the company, founded in 2016, only sought FDA approval in early 2022 – and the agency rejected the application, seven current and former employees told Reuters in March.
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.
Thursday’s FDA approval comes as US lawmakers are urging regulators 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.
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