Elon Musk's brain-implant company Neuralink on Thursday said the US Food and Drug Administration (FDA) had given the green light to its first-in-human clinical trial, a critical milestone after earlier struggles to gain approval.
The FDA nod "represents an important first step that
will one day allow our technology to help many people," Neuralink said in
a tweet. It did not elaborate on the aims of the study, saying only that it was
not recruiting yet and more details would be available soon.
Neuralink and the FDA did not immediately respond to Reuters
requests for comment.
Musk envisions brain implants could cure a range of
conditions including obesity, autism, depression, and schizophrenia as well as
enabling web browsing and telepathy. He made headlines late last year when he
said he was so confident in the devices' safety that he would be willing to
implant them in his children.
On at least four occasions since 2019, Musk predicted
Neuralink would begin human trials. But the company only sought FDA approval in
early 2022 and the agency rejected the application, seven current and former
employees told Reuters in March.
The FDA had pointed out several concerns to Neuralink that
needed to be addressed before sanctioning human trials, according to the
employees. Major issues involved the lithium battery of the device, the
possibility of the implant's wires migrating within the brain, and the
challenge of safely extracting the device without damaging brain tissue.
Neuralink, founded in 2016, has been the subject of several
federal probes.
In May, US lawmakers urged regulators to investigate whether
the makeup of a panel overseeing animal testing at Neuralink contributed to
botched and rushed experiments.
The Department of Transportation is separately probing
whether Neuralink illegally transported dangerous pathogens on chips removed
from monkey brains without proper containment measures.
Neuralink is also under investigation by the US Department
of Agriculture's Office of Inspector General for potential animal-welfare
violations. This probe has also been looking at the USDA's oversight of
Neuralink.
Neuralink has not responded to requests for comment on the
probes. © Reuters
0 comments:
Post a Comment