Elon Musk's brain-implant company Neuralink says it has 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.
Neuralink, which was founded in 2016, sought FDA approval for the first time in early 2022Elon Musk envisions both disabled and healthy individuals getting surgical implants to cure a range of different conditions
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. 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.The 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.
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