Elon Musk’s Neuralink says it has FDA approval for human brain implant research

May 25 (Reuters) – Neuralink, Elon Musk’s brain implant company, said on Thursday that the US Food and Drug Administration (FDA) had given the green light to its first human clinical trial, a critical milestone after earlier battles to gain approval .

The FDA nod “represents an important first step that will one day allow our technology to help many people,” Neuralink said in a tweet. It did not elaborate on the aims of the study, saying only that it was not yet recruiting and more details would be available soon.

Neuralink and the FDA did not immediately respond to Reuter’s requests for comment.

Musk envisions brain implants could cure a range of conditions, including obesity, autism, depression and schizophrenia, as well as enable web browsing and telepathy. He made headlines late last year when he said he was so confident in the safety of the devices that he would be willing to implant them in his children.

Since 2019, Musk has predicted at least four times that Neuralink would begin human trials. But the company didn’t apply for FDA approval until early 2022, and the agency rejected the application, seven current and former employees told Reuters in March.

The FDA had alerted Neuralink to several concerns that needed to be addressed before approving human trials, the collaborators said. Major issues related to the device’s lithium battery, the possibility of the implant’s wires migrating into the brain, and the challenge of safely removing the device without damaging brain tissue.

Founded in 2016, Neuralink has been the subject of several federal investigations.

In May, US lawmakers urged regulators to investigate whether the composition of a panel overseeing animal testing at Neuralink contributed to failed and hasty experiments.

The Department of Transportation is separately investigating whether Neuralink illegally transported dangerous pathogens on chips removed from monkey brains without proper containment measures.

Neuralink is also under investigation by the Office of Inspector General of the United States Department of Agriculture for possible animal welfare violations. This research also looked at the USDA’s oversight of Neuralink.

Neuralink has not responded to requests for comment on the probes.

Reporting by Akriti Sharma in Bengaluru; Edited by Anil D’Silva, Lincoln Feast and Edwina Gibbs

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Rachel Levy

Thomson Reuters

Award-winning corporate governance journalist. Her coverage has led to federal investigations and congressional probes and has been featured on television and podcasts. At Politico, her coverage of Covid-19 caused the CDC to update guidelines on N95 masks and the U.S. hospital regulator to look up patient safety complaints. Formerly a financial reporter with the Wall Street Journal, her exclusive coverage of the Trump White House Kodak drug deal earned her and her colleagues a 2021 Dateline Award from the Society of Professional Journalists. For news tips, you can reach her at 202-967-6233. Use Signal if it is sensitive.

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