US Authorities Allow Elon Musk to Start Human Testing of His Brain Chip

Elon Musk's brain implant company Neuralink said the US Food and Drug Administration (FDA) has given the green light to the first human clinical trial. Writes about it to Reuters.

Photo: IStock

The FDA approval “represents an important first step that will one day allow our technology to help many people,” Neuralink said in a tweet. The company did not elaborate on the purpose of the study, only stating that recruitment has not yet begun and more details will 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

Musk suggests that brain implants could cure a range of conditions, including obesity, autism, depression and schizophrenia, as well as provide web browsing and telepathy. Late last year, he made headlines when he said he was so confident in the safety of the devices that he was willing to implant them in his children.

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At least four times since 2019, Musk has predicted that Neuralink would begin human trials. But the company only requested FDA approval in early 2022, when the agency rejected the application.

The FDA pointed Neuralink to several issues that needed to be addressed before it could authorize human trials, the staff said.

The main concerns are related to the device's lithium battery, the possibility of implant wires migrating inside the brain, and the problem of safely removing the device without damaging brain tissue.

Neuralink, founded in 2016, has been the subject of several federal investigations.

In May, US lawmakers called on regulators to investigate whether the composition of the team overseeing animal trials at Neuralink contributed to the failed and hasty experiments.

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The Department of Transportation is separately investigating whether Neuralink was illegally transporting dangerous pathogens on chips extracted from monkey brains without proper containment measures.

Neuralink is also under investigation by the USDA's Office of the Inspector General for possible animal rights violations.

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