Elon Musk’s brain-implant company Neuralink on Thursday said that the US Food and Drug Administration (FDA) has given the green light to its first-in-human clinical trial, a critical milestone after earlier struggles to gain approval.
The FDA nod “represents the significant first step that will one day allow our technology to support many people,” Neuralink said in a tweet. It didn’t elaborate on the study’s aims, saying that it wasn’t recruiting yet and that more information would be available soon.
We are excited to share that we have received the FDA’s approval to launch our first-in-human clinical study!
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…
— Neuralink (@neuralink) May 25, 2023
Neuralink and the FDA didn’t immediately respond to Reuters requests for comment.
Musk envisions brain implants could cure various conditions, including obesity, autism, depression and schizophrenia, and enable 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 ex-workers told Reuters in March.
According to the employees, the FDA had pointed out many concerns to Neuralink that needed to be addressed before sanctioning human trials. Significant problems involved the device’s lithium battery, 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 many federal probes.
In May, United States lawmakers urged regulators to investigate whether the makeup of the panel overseeing animal testing at Neuralink contributed to botched and rushed experiments.
The Department of Transportation is probing whether Neuralink illegally transported dangerous pathogens on chips removed from monkey brains without proper containment measures.
Neuralink is also under investigation by the United States Department of Agriculture’s Office of Inspector General for potential animal-welfare violations. This probe has been looking at the USDA’s oversight of Neuralink.
