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Neuralink, Elon Musk’s brain-implant company, said it received approval from the US Food and Drug Administration to conduct human clinical trials.
“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 technology to help many people,” the company said Thursday in a tweet.
The FDA and Neuralink did not immediately respond to requests for comment.
Musk’s startup is developing a small device that will link the brain to a computer, consisting of electrode-laced wires. Placing the device requires drilling into the skull.
The approval “is really a big deal,” said Cristin Welle, a former FDA official and an associate professor of neurosurgery and physiology at the University of Colorado.
“They can initiate human trials, which means they have passed the safety preclinical testing and the bench testing,” she said, meaning testing for mechanical and design flaws, as well as for longevity and biocompatibility.
Founded in 2016, Neuralink attracted some top neuroscientists to work on its brain implant, although many have since moved on to other companies or academia.
Musk, who also runs carmaker Tesla Inc. and owns social network Twitter, has for years said that the company was close to FDA approval for in-human trials.
The company’s device aims to help people with paralysis or traumatic brain injuries communicate and control a computer using only their thoughts.
Eventually, aside from helping people who are sick, Musk has hypothesized that the device could enable humankind to keep up with advances being made by artificial intelligence.– Bloomberg
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