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Neuralink, Elon Musk’s brain implant company, announced Thursday night that it has received regulatory approval to conduct the first human clinical trial of its experimental device.
Approval by the U.S. Food and Drug Administration would be a milestone for the company, which is developing a device that is surgically inserted into the brain by a robot and is capable of decoding brain activity and linking it to computers. So far, the company has only conducted research on animals.
“We are pleased to announce that we have received FDA approval to begin our first human clinical trial!” Neuralink announced on TwitterHe called it “an important first step that will one day allow our technology to help many people.” Musk retweeted the contribution and congratulates his team.
The FDA and Neuralink did not immediately respond to requests for comment late Thursday.
Musk has previously prematurely touted regulatory approval. In 2017, he wrote on Twitter that his tunneling company, The Boring Company, had received “verbal government approval” for an underground hyperloop from New York to DC. Officials at the time gave no direct confirmation of Musk’s claim — and it was clear that no formal action had been taken to approve such a project.
The race against Elon Musk to put chips in people’s brains
Founded in 2016, Neuralink is privately held with offices in Fremont, California and a sprawling campus under construction outside of Austin. The company employs more than 400 people and has raised at least $363 million, according to data provider PitchBook.
With Musk’s backing, Neuralink has brought extraordinary resources — and investor attention — to an area known as the brain-computer interface, where scientists and engineers are developing electronic implants that would decode brain activity and relay it to computers. Such technology, which has been in the works for decades, has the potential to restore functioning to people with paralysis and debilitating conditions such as amyotrophic lateral sclerosis.
Companies like Blackrock Neurotech and Synchron have already implanted their devices in humans for clinical trials, and at least 42 people worldwide have received brain-computer implants. Such devices have enabled feats that once belonged in the realm of science fiction: a paralyzed man smacking Barack Obama with a robotic hand; a patient with ALS types by thinking about keystrokes; A quadriplegic patient who manages to walk with slow but natural steps.
While most companies looking to commercialize brain implants focus on people with medical needs, Neuralink has even bigger ambitions: to develop a device that not only restores human function, but improves it.
“We want our technology to exceed the capabilities of a human being,” says Neuralink tweeted In April.
Elon Musk says Neuralink is about six months away from human trials
What is Neuralink’s brain chip technology?
The company has developed a computer chip fitted with electrodes that is sewn into the surface of the brain and a robotic device to perform the surgery. Musk envisions the devices could be upgraded regularly.
“I’m pretty sure you don’t want the iPhone 1 stuck in your head when the iPhone 14 is available,” Musk said at an event in late November where he predicted that Neuralink would be out in six months of trials would begin with humans.
Although a significant milestone, a human clinical trial of the device is not a guarantee of regulatory or commercial success. Neuralink and others face intense FDA scrutiny of the safety and reliability of their devices, as well as ethical and safety issues raised by a technology that could provide a cognitive advantage to implant recipients.
When will human clinical trials begin?
It’s unclear when clinical trials might begin.
The brain-computer interface represents one of Musk’s most ambitious bets in a business empire that ranges from electric cars to rockets that put people into space — and that has recently expanded to include generative artificial intelligence and social media .
Musk founded a company, X.AI, earlier this year that aims to compete with Microsoft and Google after the tech giants launched large language-model chatbots capable of answering a variety of queries.
Meanwhile, in recent months he has devoted much of his time to Twitter, the social media company he bought for $44 billion last year in a bid to restore “free speech.”
Musk’s hectic schedule forces him to juggle obligations to each of the companies at once. He tours the country on a private jet, visits its Tesla factories and SpaceX launch sites, volunteers as a Twitter speaker, and visits its Bay Area headquarters—sometimes all in the same week. Musk announced earlier this month that he would appoint advertising executive Linda Yaccarino as Twitter’s CEO, relieving him of some responsibility for overseeing the social media platform, which has descended into chaos since its acquisition last year .