Musk’s Neuralink wins approval for first human trials

Elon Musk’s brain-implant company, Neuralink, says the US food and drug administration has given the green light to its first-in-human clinical trial, a milestone after earlier struggles to gain approval.

The approval “represents an important first step that will one day allow our technology to help many people”, Neuralink said.

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 Food and Drug Administration did not immediately respond to requests for comment.

TELEPATHY

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 approval in early 2022 and the agency rejected the application, seven current and former employees said in March.

The food and drug administration had pointed out several concerns to Neuralink that needed to be addressed before sanctioning human trials, according to the employees.

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 legislators urged regulators to investigate whether the makeup of a panel overseeing animal testing at Neuralink contributed to botched and rushed experiments. The US 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 for potential animal-welfare violations.

This probe has also been looking at the department’s oversight of Neuralink.