Billionaire Elon Musk's brain implant company Neuralink said on May 26 that it had been granted permission by the US Food and Drug Administration (FDA) to conduct clinical trials on humans, AP reported.
Neuralink is one of several research groups working to link the nervous system to computers in an effort to find ways to treat brain disorders, brain injuries, and related issues. The announcement was made in a Twitter post, but the company did not provide details about a potential study.
Neuralink has been granted FDA approval for human clinical trials
Neuralink also said that they have not recruited study participants yet and will provide more information in the near future.
The FDA also confirmed that it had given Neuralink permission to use the brain implant and surgical robot for testing on patients, but declined to provide further details. Neither Neuralink nor Musk responded to Reuters requests for comment.
This is seen as a major milestone for Neuralink as the startup faces intense scrutiny over how it conducts animal experiments.
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In May 2023, US lawmakers called for an investigation into whether the board overseeing animal testing at Neuralink rushed the research, leading to failures, following several previously reported incidents.
Specifically, last year, Neuralink employees told Reuters that the company rushed and botched surgeries on monkeys, pigs, and sheep, resulting in more animal deaths than necessary.
Earlier in 2021, the company implanted the wrong-sized device in 25 of 60 pigs, causing all of them to die — an error that employees said could have been easily avoided with better preparation.
The Department of Transportation is also separately investigating whether Neuralink illegally transferred dangerous pathogens onto chips taken from monkey brains without proper containment measures.
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