Elon Musk’s Neuralink Gets FDA Approval for Human Trials: What You Need to Know

Neuralink, Elon Musk’s brain implant company, said Thursday night that it has regulatory approval to conduct the first human clinical trial of the experimental device.

Approval by the US Food and Drug Administration would mark a milestone for the company, which has developed a device surgically inserted into the brain of a robot capable of decoding brain activity and connecting it to computers. Until now, the company has only conducted research on animals.

“We are excited to share that we have received FDA approval to launch our first-in-human clinical trial!” Neuralink announced on Twitter, calling it “an important first step that will one day allow our technology to help many people.” Musk the retweet post, and congratulate his team.

The FDA and Neuralink did not immediately respond to requests for comment late Thursday.

Musk has prematurely announced regulatory approval before. In 2017, he wrote on Twitter that his tunnel company, The Boring Company, has received “verbal approval from the authorities” for an underground Hyperloop from New York to DC. Officials at the time did not provide direct confirmation of Musk’s claim – and it was clear that formal steps to approve such a project had not been taken.

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

Founded in 2016, Neuralink is privately held with operations in Fremont, California, 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 support, Neuralink has brought extraordinary resources — and investor attention — to a field known as brain-computer interfaces, where scientists and engineers develop electronic implants that can 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 such as amyotrophic lateral sclerosis.

Already, companies such as Blackrock Neurotech and Synchron have implanted their devices in humans 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 who is able to walk with a slow but natural step.

While most companies looking to commercialize brain implants are focused on those with medical needs, Neuralink has even bigger ambitions: to create a device that not only restores human function, but enhances it.

“We want to surpass able-bodied people with our technology,” 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 designed an electrode-loaded computer chip to be sewn into the surface of the brain, and a robotic device to perform the operation. Musk envisions the devices being able to be upgraded regularly.

“I’m pretty sure you won’t have 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.

Although a significant milestone, a clinical trial of the device in humans is no guarantee of regulatory or commercial success. Neuralink and others will have to face intense scrutiny by the FDA that their devices are safe and reliable, as well as ethical and safety questions raised by a technology that could provide a cognitive advantage to those with an implant.

When do clinical trials on humans begin?

It is unclear when clinical trials may begin.

The brain-computer interface represents one of Musk’s most ambitious efforts in a business empire that ranges from electric cars to rockets that propel humans into space — which has grown to include generative artificial intelligence and social media.

Earlier this year, Musk incorporated a company, X.AI, that aims to compete with Microsoft and Google after the tech giants launched large chatbots with language models that can answer a wide range of questions.

Meanwhile, he has devoted much of his time in recent months to Twitter, the social media company he bought last year for $44 billion and pledged to restore “freedom of speech.”

Musk’s frenetic schedule has him juggling commitments to each of the companies simultaneously. He travels the country by private jet, visiting Tesla factories and SpaceX launch sites and engaging in speaking engagements for Twitter and visiting the Bay Area headquarters — sometimes all in the same week. Musk announced earlier this month that he was naming ad chief Linda Yaccarino as CEO of Twitter, relieving him of some of the responsibility of overseeing the social media platform, which has been thrown into chaos since he took over last year.

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