FDA allegedly rejects Musk's request to test Neuralink chip in humans over safety concerns

The FDA outlined a number of issues that reportedly need addressing before Neuralink can be approved for human testing, including concerns over its lithium battery.


Elon Musk has long touted his medical device company Neuralink and devices in production including a chip that can be implanted in the brain. Uses for this chip, according to Elon Musk, include treating conditions like paralysis and blindness. It’s reported by outlets like Reuters that Neuralink sought permission from the U.S. Food and Drug Administration (FDA) In early 2022 to test its chip in humans.

However, this application has since been rejected, as shared anonymously by seven current and former employees interviewed by Reuters. The rejection wasn’t previously reported on, but as disclosed by Reuters, the FDA’s decision reportedly cited a myriad of issues that Neuralink will need to address before human testing can be considered.

Image example of the construction of the Neuralink brain chip showing things like the link and neural threads
An example of Neuralink's brain chip as shared on the company's website.

© Neuralink

Among the main safety concerns over Neuralink’s chip include its lithium battery, potential for wires to migrate to other areas of the brain, and questions over how the chip can be removed without damaging brain tissue. Following the FDA's rejection, Neuralink has been working to address the agency’s concerns, as expressed to Reuters by three staff members.

With that being said, it’s worth noting that Neuralink itself has yet to disclose the details of its FDA application or its rejection. Neuralink officials and Elon Musk also didn’t respond to Reuters’ requests for comment, and Neuralink sources declined to provide Reuters with the agency’s written rejection as it’s a legally confidential document.

“The staffers, including four who had read the FDA document and others aware of the agency’s concerns, described the safety issues in interviews, speaking on condition of anonymity,” Reuters explained.

An illustrated example of how the Neuralink brain chip would be implanted
© Neuralink

Back in December, Elon Musk stressed the importance of being careful and certain the device will work before implanting it into a human.

“We want to be extremely careful and certain that it will work well before putting a device into a human," Musk said in December, as quoted by Reuters. "The progress at first, particularly as it applies to humans, will seem perhaps agonizingly slow, but we are doing all of the things to bring it to scale in parallel. So, in theory, progress should be exponential."

It’ll be interesting to see moving forward whether Neuralink will meet Elon Musk’s target of securing FDA-approved human trials in 2023, and whether more information about the device in the months ahead. While we wait to hear more about Neuralink's brain chip, be sure to brush up on some of our previous coverage including Musk saying that he will be an early adopter of Neuralink brain chips, and Neuralink falling under investigation for alleged transportation of contaminated devices.

Senior Editor

Morgan is a writer from the frozen wastelands of Maine who enjoys metal music, kpop, horror, and indie games. They're also a Tetris fanatic who's fiercely competitive in games like Tetris 99... and all games in general. But mostly Tetris. You can follow Morgan on Twitter @Author_MShaver.

Hello, Meet Lola