The US Food and Drug Administration (FDA) has given the go-ahead for Neuralink, Elon Musk’s brain implant business, to conduct its first-in-human clinical trial, marking a significant advancement following previous difficulties in obtaining approval.
The FDA’s endorsement “represents an important first step that will one day allow our technology to help many people,” Neuralink tweeted. It just mentioned that it was yet to recruit and that further information would be available soon without going into detail about the study’s objectives.
Neuralink or the FDA did not immediately answer requests for comment from Reuters.
Musk believes that brain implants might enable telepathy and the ability to browse the internet and treat several illnesses like obesity, autism, depression, and schizophrenia. He gained notoriety late last year when he declared that he would be willing to have his children implanted with the devices due to his extreme confidence in their safety.
Since 2019, Musk has forecasted the start of human trials for Neuralink at least four times. Seven current and former workers told Reuters in March that the corporation only requested FDA permission in early 2022, and the agency denied the proposal.
According to the staff, Neuralink had received various issues from the FDA that needed to be addressed before approval of human trials. The implant’s lithium battery, the potential for implant wires to migrate inside the brain, and the difficulty of securely removing the device without injuring brain tissue were the main problems.
The 2016-founded Neuralink has been the focus of numerous federal investigations.
US lawmakers encouraged regulators to investigate whether the composition of the panel in charge of Neuralink’s animal testing was a factor in May’s hurried and flawed trials.
The Department of Transportation is conducting separate investigations to determine whether Neuralink transferred harmful germs on chips taken from monkey brains without the required containment procedures.
The Office of Inspector General for the US Department of Agriculture also looks into Neuralink for possible animal welfare breaches. The USDA’s supervision of Neuralink has also been the subject of this investigation.
Requests for comment on the probes from Neuralink have yet to receive a response.