- The FDA rejected Neuralink's request for approval to begin testing its brain chips in humans, Reuters reported.
- The agency cited dozens of issues with the device, including concerns it could overheat or move in the brain.
Neuralink's attempt to receive approval from the US Food and Drug Administration was rejected last year, according to a new report from Reuters.
Since 2019, Musk has repeatedly set and missed his own projections for when Neuralink, his brain chip startup, would begin implanting its devices in human brains. But the company only began requesting the FDA's permission for human trials last year, Reuters reported, citing seven current and former Neuralink employees.
Reuters said the FDA identified "dozens of issues" Neuralink must remedy before it could begin human testing in the US. The FDA said there were a number of safety concerns, per Reuters, including that the brain chip's wires could move into other areas in the test subject's brain and that the chip could overheat and damage tissue, Reuters reported. There were also concerns around how the implant would be removed without damaging the brain, per Reuters.
A spokesperson for Neuralink did not respond to a request for comment ahead of publication, and the company has not indicated it's application has been rejected. In December, Musk said that the company would be approved for human trials by the spring of 2023. At the time, the billionaire said he was so confident in the device that he'd have it implanted in his own brain.
To date, Neuralink has yet to test on humans and has instead experimented with the device on animals, including pigs and monkeys. Last year, Musk showed a demo video of a monkey with an implant "telepathically typing."
The Reuters report comes after the US Department of Transportation said it was investigating Musk's startup following a claim from an animal rights group that Neuralink had transported potentially hazardous pathogens by moving the brain chips after they had been removed from animal test subjects without following federal regulations.
Musk cofounded Neuralink in 2016 as a brain-computer interface company. The firm plans to implant chips into human brains, which would allow people to perform tasks using only their mind. The billionaire has said in the past that Neuralink's chips — which are coin-sized devices designed to be implanted in the brain via a surgical robot — could one day do anything from cure paralysis to give people telepathic powers, referring to the device as "a Fitbit in your skull."