Elon Musk said Neuralink is ready for humans. Regulators disagree, deny application for human trials.

Application denied. That’s what regulators with the U.S. Food and Drug Administration (FDA) had to tell Elon Musk’s brain implant company, Neuralink, after it sought the green light to begin human trials.

Furthermore, it seems unlikely that Neuralink will receive an approval soon, at least not within any timeframes that Musk has previously mentioned.

The news of the FDA’s denial of Neuralink’s application comes from a new report by Reuters(Opens in a new tab). The outlet spoke to more than half a dozen current and former employees who shared details of the rejection, which actually came about a year ago. The FDA’s denial was not publicly known before.

Musk has shared his grand vision for Neuralink a number of times over the years. According to Musk, once a Neuralink chip is implanted into a patient’s brain, it could help restore vision to the blind and even help paralyzed people walk again. Musk has gone even further, imagining features where the chip could record people’s memories so they can reminisce about moments they otherwise may have forgotten.

As for why the FDA denied Neuralink’s application to begin human trials, sources said there were “dozens of issues the company must address.” Some of the FDA’s safety concerns involve the potential for the device’s wires to “migrate” and damage other areas of the brain, potential issues with the lithium battery in the device, and whether a procedure to surgically remove the device would damage a patient’s brain tissue.

Likely furthering those safety concerns are the investigations into Neuralink possibly violating animal welfare laws while attempting to rush development. According to a previous report, also by Reuters(Opens in a new tab), approximately 1,500 monkeys, pigs, and mice have been killed undergoing Neuralink testing since 2018.

“Neuralink doesn’t appear to have the mindset and experience that’s needed to get this to market anytime soon,” a former program director for neural engineering in the U.S. National Institutes of Health (NIH) told Reuters.

As the report lays out, Neuralink formed in 2016, but didn’t apply for approval from the FDA for trials until early 2022, only to have that application denied. Musk appears to have nonetheless been making claims that were impossible to deliver on due to the company not having yet applied for FDA approval, let alone received it.

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For example, during a Neuralink presentation in 2019, Musk said(Opens in a new tab) the company was looking to be approved for human trials by regulators by the end of 2020. In early 2021(Opens in a new tab), Musk tweeted a reply to a man who was paralyzed in a car accident that Neuralink was in “close communication with the FDA” and the company “might be able to do initial human trials” later that year, even though it hadn’t applied.

But, Musk’s most specific timeline for human trials came just around three months ago.

“We are now confident that the Neuralink device is ready for humans, so timing is a function of working through the FDA approval process,” Musk tweeted(Opens in a new tab).

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Then at Neuralink’s “Show and Tell(Opens in a new tab)” event that same day, Musk said he could get the implant right now and put a six-month timeframe on when he expects the human trials to begin. There are 90 days left for those trials to begin as promised.