application rejectedThis is what regulators at the U.S. Food and Drug Administration (FDA) had to tell Elon Musk’s brain implant company, Neuralink, after asking for the go-ahead to begin human trials.
Additionally, it seems unlikely that Neuralink will receive approval anytime soon. At least not within the timeframe Musk previously mentioned.
The news that the FDA has rejected Neuralink’s application New report by Reuters(opens in new tab)The outlet actually spoke with more than six current and former employees who shared details of the denial that took place about a year ago. I did.
Musk has shared Neuralink’s grand vision many times over the years. Musk said that a Neuralink chip implanted in a patient’s brain could restore sight to blind people and even enable paralyzed people to walk again. Musk goes further and envisions the ability of chips to record people’s memories and recall moments they might otherwise have forgotten.
Elon Musk’s Neuralink reportedly under investigation for animal welfare violations
As to why the FDA rejected Neuralink’s application to initiate human trials, a source said, “There are dozens of issues the company has to grapple with.” FDA safety concerns include the possibility of the device’s wires “moving” and damaging other areas of the brain, potential issues with the lithium battery in the device, and the procedure for surgically removing the device. damages the patient’s brain tissue. .
It may be Neuralink’s research that likely fuels these safety concerns. violating Animal Welfare Act while rushing to develop. According to previous reports, Reuters(opens in new tab)about 1,500 monkeys, pigs, and mice have been put through Neuralink tests and killed since 2018.
A former program director for neural engineering at the National Institutes of Health (NIH) told Reuters, “Neuralink doesn’t seem to have the mindset and experience necessary to bring this to market quickly.”
As the report shows, Neuralink was founded in 2016 but didn’t submit to the FDA for approval of the study until early 2022. The application was denied. Nonetheless, Musk apparently made claims that were unfeasible because the company had not yet applied for, much less received, FDA approval.
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For example, in a 2019 Neuralink presentation, Musk said Said(opens in new tab) The company was aiming to receive regulatory approval for human trials by the end of 2020. 2021(opens in new tab)Musk told a man who was paralyzed in a car accident that Neuralink was “in close contact with the FDA,” and that later that year, even though the company hadn’t filed, it would “do the first human trial. I might be able to,” he tweeted in reply. .
But the most concrete timeline for Musk’s human trials came out just three months ago.
“We are confident that the Neuralink device is ready for human use, so the timing will be determined through the FDA approval process,” Musk said. murmured(opens in new tab).
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Next, Neuralink’s “show and tell(opens in new tab)” Event on the same day, mask Said He was able to get his implants now and put a six-month timeframe where human trials are expected to begin.
