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 company, founded in 2016, did not seek permission from the FDA until early 2022 – and the agency rejected the application, seven current and former employees 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 has also been looking at the USDA’s oversight of Neuralink.
In a tweet on Thursday, Neuralink said that the company is not yet open for a clinical trial.
“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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