Elon Musk’s brain-computer interface company Neuralink announced Thursday that it has received approval from the U.S. Food and Drug Administration (FDA) to launch its first human clinical study. This means that Neuralink will implant their device into the human brain.
Neuralink announced on Twitter Thursday, “We are excited to say that we have received FDA approval to launch our first human clinical study! This is the result of amazing work by the Neuralink team in close collaboration with the FDA and is an important first step toward the day when our technology can help many people. Our clinical trial has not yet begun enrolling. We will be announcing more information soon!”
Neuralink Says Human Trial Application Approved by FDA
Previously, Neuralink founder Musk had said last November that Neuralink was about six months away from its first human trial. This time, Musk made good on his promise in a rare fashion. While being approved for human trials is not as huge a milestone as achieving clinical trial results, this is no ordinary trial, after all. It represents Neuralink’s bid to implant its device into the human brain.
It should be noted that Neuralink is not the first company to receive approval to implant brain-machine interfaces in humans; Synchron received FDA approval to begin trials in the U.S. in 2021 and announced the first brain-machine interface implant in the U.S. last July. In January, it published early results from a study of four human patients in Australia.
However, Neuralink has also previously been accused of abusing monkeys in experiments that led to their deaths, which Neuralink denies. The FDA reportedly rejected Neuralink’s application for human trials in early 2022, citing “dozens of issues” that the company needs to address.
So, who would sign up for such a trial and why? Would the volunteer be someone with an important medical reason? Is someone who wants to draw the world’s attention to Musk? Or Musk himself? Musk has claimed that he will have the brain-machine interface device implanted in his head at some point in the future, but the exact timing is unknown.