Elon Musk's brain-implant company Neuralink on Thursday said the U.S. Food and Drug Administration (FDA) had given the green light to its first-in-human clinical trial, a critical milestone after earlier struggles to gain approval.
The FDA nod "represents an important first step that will one day allow our technology to help many people," Neuralink said in a tweet. It did not elaborate on the aims of the study, saying only that it was not recruiting yet and more details would be available soon.
Neuralink and the FDA did not immediately respond to Reuters requests for comment.
Musk envisions brain implants could cure a range of conditions including obesity, autism, depression and schizophrenia as well as enabling web browsing and telepathy. He made headlines late last year when he said he was so confident in the devices' safety that he would be willing to implant them in his children.
On at least four occasions since 2019, Musk predicted Neuralink would begin human trials. But the company only sought FDA approval in early 2022 and the agency rejected the application, seven current and former employees told Reuters in March.
On at least four occasions since 2019, Musk predicted Neuralink would begin human trials. But the company only sought FDA approval in early 2022 and the agency rejected the application, seven current and former employees told Reuters in March.
The FDA had pointed out several concerns to Neuralink that needed to be addressed before sanctioning human trials, according to the employees. Major issues involved the lithium battery of the device, the possibility of the implant's wires migrating within the brain, and the challenge of safely extracting the device without damaging brain tissue.
Neuralink, founded in 2016, has been the subject of several federal probes.
In May, U.S. lawmakers urged regulators to investigate whether the makeup of a panel overseeing animal testing at Neuralink contributed to botched and rushed experiments.
Musk has prematurely touted regulatory approval before. In 2017, he wrote on Twitter that his tunneling firm, The Boring Company, has received “verbal govt approval” for an underground Hyperloop from New York to DC. Officials at the time offered no direct confirmation of Musk’s claim — and it was clear formal measures to approve such a project had not been taken.
The Department of Transportation is separately probing whether Neuralink illegally transported dangerous pathogens on chips removed from monkey brains without proper containment measures.
Neuralink is also under investigation by the U.S. Department of Agriculture's Office of Inspector General for potential animal-welfare violations. This probe has also been looking at the USDA's oversight of Neuralink.
We are excited to share that we have received the FDA’s approval to launch our first-in-human clinical study!
— Neuralink (@neuralink) May 25, 2023
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…
And it makes us wonder: who would sign up for such a thing, and why? Will it be someone who might have an important medical reason or someone who wants to draw the world’s attention at Musk’s side, and is there any chance it’s Elon Musk himself? Musk has claimed he will get the device implanted in his own head at some unspecified time in the future.
Meanwhile, Neuralink has been accused of abusing its monkey test subjects, a claim the company denies, and is under investigation for allegedly transporting contaminated devices removed from monkeys. The FDA rejected an early 2022 Neuralink application for human trials, as reported by Reuters, apparently outlining “dozens of issues” the company needed to address.
What is Neuralink?
Founded in 2016, Neuralink is privately held with operations in Fremont, Calif., and a sprawling, under-construction campus outside of Austin. The company has more than 400 employees 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 a field known as brain-computer interface, where scientists and engineers are developing electronic implants that would decode brain activity and communicate it to computers. Such technology, which has been in the works for decades, has the potential to restore function to people with paralysis and debilitating conditions like amyotrophic lateral sclerosis.
Already, companies like Blackrock Neurotech and Synchron have implanted their devices in people for clinical trials, and at least 42 people globally have had brain-computer implants. Such devices have enabled feats that once belonged to the realm of science fiction: a paralyzed man fist-bumping Barack Obama with a robotic hand; a patient with ALS typing by thinking about keystrokes; a tetraplegic patient managing to walk with a slow but natural stride.
While most companies seeking to commercialize brain implants are focused on those with medical needs, Neuralink has even bigger ambitions: creating a device that not only restores human function but enhances it.
“We want to surpass able-bodied human performance with our technology,” Neuralink tweeted in April.
,We want to surpass able-bodied human performance with our technology. Using only his mind, here's precision cursor control from Pager (star of Monkey MindPong) achieving 65% and 88% of the median Neuralinker using a mouse. Join us to breakthrough to 110% and beyond!🧠#techtuesday pic.twitter.com/Ugtav0h7Mg
— Neuralink (@neuralink) April 19, 2023
What is Neuralink’s brain chip technology? The company has designed an electrode-laden computer chip to be sewed into the surface of the brain, and a robotic device to perform the surgery. Musk envisions that the devices could be regularly upgraded.
“I’m pretty sure you would not want the iPhone 1 stuck in your head if the iPhone 14 is available,” Musk said at an event in late November, where he predicted Neuralink would begin human trials in six months.
“I’m pretty sure you would not want the iPhone 1 stuck in your head if the iPhone 14 is available,” Musk said at an event in late November, where he predicted Neuralink would begin human trials in six months.
While a significant milestone, a clinical trial for its device in humans is no guarantee of regulatory or commercial success. Neuralink and others are bound to face intense scrutiny by the FDA that their devices are safe and reliable, in addition to facing ethical and security questions raised by a technology that could confer a cognitive advantage to those with an implant.
When will clinical trials in humans begin? It is unclear when clinical trials might begin.
The brain-computer interface represents one of Musk’s most ambitious bets in a business empire that spans from electric cars to rockets propelling humans to space — that has grown to most recently encompass generative artificial intelligence and social media.
Musk earlier this year incorporated a company, X.AI, that aims to compete with Microsoft and Google after the tech giants launched large language-model chatbots that can answer a vast range of queries.
Meanwhile, he has been devoting much of his time in recent months to Twitter, the social media company he purchased last year for $44 billion pledging to restore “free speech.”
Musk’s frenetic schedule has him juggling commitments to each of the companies at once. He travels the country by private jet, visiting his Tesla factories and SpaceX launch sites and engaging in speaking commitments for Twitter and visiting its Bay Area headquarters — sometimes all in the same week. Musk earlier this month announced he was appointing advertising executive Linda Yaccarino as CEO of Twitter, relieving him of some of the responsibility for overseeing the social media platform that has been plunged into chaos since his takeover last year.
