Bangalore: Elon Muskbrain implant company Neuralink on Thursday said he had received the green light from the US Food and Drug Administration (FDA) to launch its first in humans clinical studya critical milestone after previous struggles to win approval.
On at least four occasions since 2019, Musk has predicted that his medical device company would start human trials for brain implant to treat severe conditions such as paralysis and blindness.
However, the company, founded in 2016, only sought FDA approval in early 2022, and the agency rejected the request, seven current and former employees told a news agency in March.
The FDA had flagged several concerns to Neuralink that needed to be addressed before sanctioning human trials, according to the employees. The main issues involved the device’s lithium battery, the possibility of implant wires migrating into the brain, and the challenge of safely removing the device without damaging brain tissue.
Thursday’s FDA approval comes as US lawmakers urge regulators to investigate whether the composition of a panel overseeing animal testing at Neuralink contributed to botched and rushed experiments.
Neuralink has already been the subject of federal investigations. The Reuters news agency reported on December 5 that the USDAThe Inspector General was investigating, at the request of a federal prosecutor, possible violations of the Animal Welfare Lawthat governs how researchers treat and test certain types of animals.
The probe has also been analyzing the USDANeuralink supervision. In a tweet Thursday, Neuralink said it’s not open for a clinical trial yet.
“This is the result of incredible work by the Neuralink team in close collaboration with the FDA and represents an important first step that will one day allow our technology to help many people,” Neuralink said in a tweet on Thursday.
Over the years, Musk has publicly outlined an ambitious plan for Neuralink. He made headlines late last year when he said he was already so confident in the safety of the devices that he would be willing to implant them in his own children.
Musk envisions both disabled and able-bodied people quickly getting surgical implants at local centers. These devices aim to cure a variety of conditions, from obesity, autism, depression, schizophrenia, to enabling web browsing and telepathy. The FDA did not immediately respond to a Reuters request for comment.
