Neuralink obtains FDA approval to begin clinical human trials of its brain computer interface

Credit: Neuralink

Neuralink has announced it received approval from the Food and Drug Administration (FDA) to launch a clinical study of its brain-computer interface (BCI) involving humans.

Neuralink was founded by CEO Elon Musk in 2016, and in recent years has been testing its BCI on animals with the initial goal of implanting chips in the brains of humans to restore vision or give people with spinal cord injuries the ability to control their computers and mobile devices with their thoughts. We have so far seen demonstrations of the technology through a 9-year old Macaque named Pager who played the video game Pong using only her mind.

That was over two years ago, but back in December 2022 we saw another demonstration with another monkey who helped type the phrase ‘welcome to show and tell’ by focusing on highlighted words and letters. It was during that presentation that Musk said the company had submitted most of the documentation required for human trials to the FDA, and that approval and the first human implant could take place in about six months.

While Musk isn’t always accurate with his timelines, this time he was. On Thursday the company announced on Twitter it had received FDA approval to begin human clinical trials.

Even though Neuralink now has FDA approval, it is unclear when the first human trials will begin. In their announcement tweet, the company said “recruitment is not yet open.” However they have given themselves a bit of a headstart as for the last few months a “Patient Registry” has been on their website where interested parties could sign up to find out whether they may qualify for future Neuralink clinical trials.

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