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Neuralink, Elon Musk’s brain-implant company, said Thursday evening that it has regulatory approval to conduct the first clinical trial of its experimental device in humans.

Approval by the U.S. Food and Drug Administration would mark a milestone for the company, which has been developing a device surgically inserted into the brain by a robot and capable of decoding brain activity and linking it to computers. Up until now, the company has conducted research only in animals.

“We are excited to share that we have received the FDA’s approval to launch our first-in-human clinical study!” Neuralink <a href="https://twitter.com/neuralink/status/1661857379460468736" target=_blank>announced on Twitter</a>, calling it “an important first step that one day will allow our technology to help many people.” Musk <a href="https://twitter.com/elonmusk/status/1661897511337082880" target=_blank>retweeted </a>the post, congratulating his team.

Neuralink didn’t immediately respond to<b> </b>a request for comment late Thursday.

The FDA doesn’t typically confirm approvals for human clinical trials but offered a statement Friday. “The FDA acknowledges and understands that Neuralink has announced that its investigational device exemption … for its implant/R1 robot was approved by the FDA and that it may now begin conducting human clinical trials for its device,” an agency spokesperson said in a statement Friday.

Musk has prematurely touted regulatory approval in the past. In 2017, <a href="https://www.washingtonpost.com/local/trafficandcommuting/musk-says-he-has-verbal-approval-for-dc-to-new-york-hyperloop/2017/07/20/0754628e-6d62-11e7-b9e2-2056e768a7e5_story.html" target=_blank>he wrote on Twitter</a> that his tunneling firm, the Boring Company, had received “verbal govt approval” for an underground Hyperloop from New York to Washington, D.C. Officials at the time offered no direct confirmation of Musk’s claim — and it was clear there were no formal measures to approve such a project.

The race against Elon Musk to put chips in people’s brains

Founded in 2016, Neuralink is a privately held firm with operations in Fremont, Calif., and a sprawling campus under construction 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 <a href="https://www.washingtonpost.com/business/2023/03/03/brain-chips-paradromics-synchron/" target=_blank>brain-computer interface</a>, 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 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 <a href="https://www.washingtonpost.com/news/to-your-health/wp/2016/10/13/in-a-medical-first-brain-implant-allows-paralyzed-man-to-feel-again/?itid=lk_inline_manual_6" target=_blank>fist-bumping President Barack Obama</a> with a robotic hand; a patient with ALS <a href="https://www.washingtonpost.com/business/2023/03/03/brain-chips-paradromics-synchron/" target=_blank>typing by thinkin</a>g about keystrokes; a tetraplegic patient <a href="https://www.washingtonpost.com/business/2023/05/24/brain-spinal-cord-implants-walk/?itid=ap_danielgilbert" target=_blank>managing to walk</a> 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 <a href="https://twitter.com/neuralink/status/1648478559093264387?cxt=HHwWhsDQ6f6gyeAtAAAA" target=_blank>tweeted </a>in April.

Elon Musk says Neuralink is about six months away from human trials

What is Neuralink’s brain chip technology?

The company has designed an electrode-laden computer chip to be sewn into the surface of the brain, and a robotic device to perform the surgery. Neuralink is pursuing a more invasive, high-bandwidth approach than some of its rivals, betting that its configuration will transfer data from brain to computer more rapidly than devices with fewer electrodes or that sit outside the brain’s surface. 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.

Neuralink has highlighted Musk’s penchant for showmanship, implanting a computer chip in a monkey and teaching him to <a href="https://www.youtube.com/watch?v=rsCul1sp4hQ" target=_blank>play the computer game Pong </a>with his mind. But the company has also given lengthy, highly technical presentations on its technology, discussing such topics as how it will mitigate the risk of brain tissue scarring and a diminishing electronic signal from the implant.

The company has also drawn criticism for its research on animals from the Physicians Committee for Responsible Medicine, which has called for an investigation into “serious safety concerns” arising from its practices.

“Musk needs to drop his obsession with sticking a device in our heads,” Ryan Merkley, director of research advocacy with the Physicians Committee, said in a statement Friday. “If he cared about the health of patients, he would invest in a noninvasive brain-computer interface.”

A clinical trial for the 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. A patient registry on Neuralink’s website indicates that only patients with certain conditions — including paralysis, blindness, deafness or the inability to speak — are eligible to participate.

The brain-computer interface is one of Musk’s most ambitious bets in a business empire that spans electric cars to rockets propelling humans to space and that has grown most recently to encompass generative artificial intelligence and social media.

Musk earlier this year <a href="https://www.washingtonpost.com/technology/2023/04/21/elon-musk-ai-startup/" target=_blank>incorporated a company, X.AI</a>, 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 <a href="https://www.washingtonpost.com/technology/2022/10/28/elon-musk-buys-twitter/" target=_blank>bought last year</a> for $44 billion while 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 giving speeches for Twitter and visiting its Bay Area headquarters — sometimes all in the same week. Musk announced earlier this month that he was appointing <a href="https://www.washingtonpost.com/technology/2023/05/12/why-linda-yaccarino-twitter-ceo-elon-musk/" target=_blank>advertising executive Linda Yaccarino</a> as Twitter’s chief executive, relieving him of some of the responsibility for overseeing the social media platform that has been plunged into chaos since his takeover last year.

University of Chicago, BA in International Studies

Daniel Gilbert joined The Washington Post in 2022 and writes about the business of medicine. He previously spent seven years as an investigative reporter for the Seattle Times, and before that covered business and energy for the Wall Street Journal.

Daniel Gilbert

University of Nebraska-Lincoln

Faiz Siddiqui is a technology reporter with The Washington Post's Business Desk covering companies such as Tesla and Twitter. His area of coverage has also included ride-hailing and the race to build autonomous cars. Prior to that, he covered the D.C. Metro and local transportation scene.

Faiz Siddiqui

Elon Musk's Neuralink gets FDA approval for human trials: What to know

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