May 25 – Elon Musk’s brain-implant company Neuralink on Thursday said it had received the U.S. Food and Drug Administration’s (FDA) approval to launch its first-in-human clinical study.
On at least four occasions since 2019, Musk has predicted that his medical device company would soon start human trials of a brain implant to treat intractable conditions such as paralysis and blindness.
Yet, the FDA rejected the FDA’s application in early 2022, according to seven former and current employees who told Reuters in March.
The FDA approval comes as U.S. lawmakers urged regulators earlier this month 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 probes.
Reuters reported on Dec. 5 that the USDA’s Inspector General was investigating, at the request of a federal prosecutor, potential violations of the Animal Welfare Act, which governs how researchers treat and test certain types of animals.
The probe also looked at USDA oversight of Neuralink.
Neuralink announced in a Thursday tweet that it is still not ready to conduct a 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 technology to help many people,” Neuralink said in a tweet on Thursday.
Neuralink is developing a brain implant it hopes will help paralyzed people walk again and cure other neurological ailments.
The FDA did not immediately respond to a Reuters request for comment.
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