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Friday, March 1, 2024

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

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 announced on Twitter, calling it “an important first step that one day will allow our technology to help many people.” Musk retweeted the post, congratulating his team.

The FDA and Neuralink didn’t immediately respond to requests for comment late Thursday.

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

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.

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 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.

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.

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