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




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

The FDA nod “represents an important first step that will one day allow our technology to help many people,”[ads1]; Neuralink said in a tweet. It did not elaborate on the aims of the study, saying only that it was not recruiting yet and that more details would be available soon.

Neuralink and the FDA did not immediately respond to Reuters requests for comment.

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

On at least four occasions since 2019, Musk predicted that Neuralink would begin human trials. But the company first sought FDA approval in early 2022, and the agency rejected the application, seven current and former employees told Reuters in March.

The FDA had raised several concerns with Neuralink that needed to be addressed before sanctioning human trials, according to the staff. Major issues involved the device’s lithium battery, the possibility of the implant’s wires migrating in the brain, and the challenge of extracting the device safely without damaging brain tissue.

Neuralink, founded in 2016, has been the subject of several federal probes.

In May, US lawmakers called on regulators to investigate whether the makeup of a panel overseeing animal testing at Neuralink contributed to flawed and rushed experiments.

The Department of Transport 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 US Department of Agriculture’s Office of Inspector General for potential animal welfare violations. This probe has 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; Editing by Anil D’Silva, Lincoln Feast and Edwina Gibbs

Our standards: Thomson Reuters Trust Principles.

Rachael Levy

Thomson Reuters

Award-winning journalist covering business management. Her reporting has led to federal and congressional investigations and been featured on television and podcasts. At Politico, her Covid-19 coverage prompted the CDC to update guidance on N95 masks and the US hospital regulator to seek patient safety complaints. A former Wall Street Journal financial reporter, her exclusive articles on the Trump White House’s Kodak drug deal won her and colleagues a 2021 Dateline Award from the Society of Professional Journalists. For news tips, reach her at 202-967-6233. If it’s sensitive, use Signal.



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