Musk’s Neuralink Says FDA Approved Human Trials

STORY: Elon Musk’s brain implant company Neuralink said on Thursday it had received the green light from the US FDA to begin its first-in-human clinical study.

This is a critical step for Neuralink after earlier difficulties in gaining approval.

On at least four occasions since 2019, Musk has said his medical device company will begin human trials for a brain implant to treat serious conditions such as paralysis and blindness.

Still, the company didn’t seek Food and Drug Administration approval until early 2022.

And the agency denied the request, sources linked to the company told Reuters in March.

The sources said the FDA flagged several concerns to Neuralink that needed to be addressed before sanctioning the human trials.

They include the device’s battery as well as safety issues surrounding its wires and the protection of brain tissue.

Thursday’s FDA approval comes as U.S. lawmakers urge regulators to investigate Neuralink’s animal testing oversight.

The company has previously been the subject of federal investigations, including at least one related to animal testing and treatment.

In a tweet on Thursday, Neuralink said it was “excited” to share the news of the approval, but is not yet recruiting for a clinical trial.

Over the years, Musk has publicly laid out an ambitious plan for Neuralink.

He envisions his devices to cure a range of conditions from obesity, autism, depression, schizophrenia, to web browsing and even telepathy.

And that disabled and healthy people would quickly get surgical implants at local centers.

Neuralink and the FDA did not immediately respond to a Reuters request for comment.


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