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By Reuters May 26, 2023 6:35:20 AM IST (Published)
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.
Elon Musk's brain-implant company Neuralink on Thursday said 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.
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On at least four occasions since 2019, Musk has predicted 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.