- The FDA rejected Neuralink’s request for permission to begin testing its brain chips on humans, Reuters reported.
- The agency cited several issues with the device, including concerns that it could overheat or activate the brain.
- Elon Musk has promised that the company will start testing people from 2019.
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 plans for when Neuralink, his brain chip startup, will begin implanting its devices in the human brain. But the company only began requesting FDA approval for human trials last year, Reuters reported, citing seven current and former Neuralink employees.
Reuters says the FDA has identified “dozens of issues” that Neuralink needs to resolve before it can begin human testing in the US. The FDA said there were several safety concerns, per Reuters, including that the brain chip’s wires could migrate to other areas of the test subject’s brain and that the chip could overheat and damage tissue, the Reuters reported. There are also concerns about how to remove the implant without damaging the brain, per Reuters.
A spokesperson for Neuralink did not respond to a request for comment before publication, and the company did not indicate that this application was rejected. Last December, Musk said the company would be approved for human trials in the spring of 2023. At the time, the billionaire said he was so confident in the device that he would glue it to his own brain.
Until now, Neuralink has not tested on humans and 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 carried potentially dangerous pathogens by moving brain chips after they were removed from animal test subjects without complying with federal regulations.
Musk founded Neuralink in 2016 as a brain-computer interface company. The company plans to implant chips in the human brain, which will allow people to perform tasks using only their mind. The billionaire previously said that Neuralink’s chips — coin-sized devices designed to be implanted in the brain by a surgical robot — could one day do anything from cure paralysis to provide people with telepathic powers, referring to the device as “a Fitbit in your skull.”
Read the full story from Reuters on its website.