Seven years after its launch, the company Neuralink by Elon Musk he finally got approval from the US Food and Drug Administration (FDA) to implant a computer inside a human brain.
“We are excited to share that we have received FDA approval to launch our first human clinical study,” Neuralink tweeted Thursday. “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.”
Neuralink is working on technology that links the human brain to a computer interface for a system that could help people with neurological conditions communicate with and control various devices. A paralyzed person, for example, could use her phone simply by imagining the movements of her hands. But according to Musk, the long-term ambition of the project is to equip humans with “superhuman cognition.”
The timing of the approval dovetails with Musk’s announcement in November 2022 that Neuralink had applied to the FDA for approval, saying at the time that he expected the regulator to take about six months to make a decision.
The big question now is precisely how Neuralink will select trial participants from those who apply.
The company said on Thursday that recruitment for the clinical trial “is not open yet,” but promised to “announce more information about this soon.”
Musk said last year that he planned to implant the device in his own brain, but few expect him to be one of the initial trial participants.
The FDA had previously raised a number of issues that it wanted Neuralink to address before considering giving the go-ahead for human trials, Reuters reported. They concerned the device’s lithium battery, the risk of the implant wires migrating into the brain, and how to ensure safe removal of the device without causing damage to brain tissue.
In an earlier demonstration of his brain implant, Neuralink showed a monkey playing Pong just by thinking about it and also moving a mouse cursor through its thoughts. The company has been criticized for its use of animals for testing, but Musk has always maintained that animals are treated humanely.
Other researchers have been developing technology similar to Neuralink. A device called BrainGatefor example, has enabled a paralyzed man to communicate his thoughts by converting his imagined writing into text.