Neuralink, Elon Musk’s brain-implant company, has received approval from the US food & drug administration (FDA) 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 on Thursday in a tweet.
The FDA and Neuralink did not respond to requests for comment.
Musk’s start-up 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 top neuroscientists to work on its brain implant, though many have since moved on to other companies or academia.
Musk also runs carmaker Tesla and owns social network Twitter.
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 hypothesised that the device could enable humankind to keep up with advances being made by artificial intelligence.
Neuralink isn’t the first brain-computer interface company to enter human trials. Synchron has already enrolled its first US patient in a clinical trial, putting the company’s implant on a path toward possible regulatory approval for wider use in people with paralysis. Synchron’s device is less invasive than Neuralink’s, and uses different technology.
Musk’s start-up has raised alarms with some animal rights groups for its testing on primates.
Despite the FDA trial approval, widespread brain implants are still not imminent. Neuralink’s device is probably at least five-10 years away from commercialisation, Welle said. Setting up a trial and recruiting patients will take several months. — Bloomberg
Would you like to comment on this article?
Sign up (it's quick and free) or sign in now.
Please read our Comment Policy before commenting.