Elon Musk’s Neuralink Gets FDA Approval: What to Know

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

Approval by the US Food and Drug Administration would be 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 connecting it to computers. So far, the company has only conducted research on animals.

“We are excited to share that we have received FDA approval to launch our first 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 retweeted the post, congratulating your team.

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

Musk has prematurely disclosed regulatory approval before. In 2017, he wrote on Twitter that his tunneling company, The Boring Company, received “verbal approval from the government” for an underground Hyperloop from New York to DC. Officials at the time did not offer direct confirmation of Musk’s claim – and it was clear that formal steps to pass 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 large 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 brain-computer interfaces, where scientists and engineers are developing electronic implants that decode brain activity and communicate it to computers. This technology, which has been in the works for decades, has the potential to restore function in people with paralysis and debilitating conditions like amyotrophic lateral sclerosis.

Companies such as Blackrock Neurotech and Synchron have already implanted their devices in people for clinical trials, and at least 42 people worldwide have had brain-computer implants. These devices enabled feats that once belonged to the realm of science fiction: a paralyzed man punching Barack Obama with a robotic hand; an ALS patient typing while thinking about the keystrokes; a quadriplegic patient managing to walk with a slow but natural step.

While most companies looking to market brain implants are focused on people with medical needs, Neuralink has even greater ambitions: to create a device that not only restores human function, but improves it as well.

“We want to surpass healthy 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 designed a computer chip loaded with electrodes to be sewn to the surface of the brain and a robotic device to perform the surgery. Musk envisions the devices being able to be updated regularly.

“I’m sure you wouldn’t want the iPhone 1 stuck in your head if the iPhone 14 was available,” Musk said at an event in late November where he predicted that Neuralink would begin human trials in six months.

While a significant milestone, a human clinical trial for its device is no guarantee of regulatory or commercial success. Neuralink and other companies are poised to face intense scrutiny from the FDA that their devices are safe and reliable, as well as ethical and safety concerns raised by a technology that could confer a cognitive advantage to those with implants.

When will human clinical trials begin?

It’s not clear when clinical trials might start.

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

Earlier this year, Musk incorporated a company, X.AI, which aims to compete with Microsoft and Google after the tech giants released large language model chatbots that can answer a vast array of queries.

Meanwhile, he’s been devoting much of his time these past few months to Twitter, the social media company he bought last year for $44 billion, promising to restore “free speech.”

Musk’s hectic schedule has him juggling appointments with each of the companies at the same time. He travels around the country on a private jet, visiting its Tesla factories and SpaceX launch sites and attending Twitter speaking engagements and visiting Bay Area headquarters — sometimes all in the same week. Earlier this month, Musk announced he was naming advertising executive Linda Yaccarino as CEO of Twitter, relieving him of some of the responsibility of overseeing the social media platform that has descended into chaos since its acquisition last year.

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