Background: FDA Approves Neuralink Clinical Trials; learn more

Neuralink, Elon Musk’s brain implant company, said Thursday evening (25) that it has regulatory approval to conduct the first clinical trial of its experimental device in humans.

The approval by the FDA (Food and Drug Administration, Anvisa of the United States) is a milestone for the company, which has developed a device surgically inserted into the brain by a robot capable of decoding brain activity and linking it to computer. So far, the company has only conducted research on animals.

“We are thrilled 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 enable our technology to help many people.” . Musk retweeted the post, congratulating his team.

The FDA and Neuralink did not immediately respond to requests for comment The New York Times.

Musk’s scoop

Musk prematurely disclosed regulatory approval earlier. In 2017, he tweeted that his tunneling company, The Boring Company, received “verbal government approval” for an underground Hyperloop from New York to Washington.

Officials at the time did not offer direct confirmation of Musk’s claim and it was clear no formal steps had been taken to approve such a project.

What is Neulink?

Companies like Blackrock Neurotech and Synchron have already implanted their devices into people for clinical trials, and at least 42 people worldwide have had brain-computer implants.

These devices have enabled feats that once belonged to the realm of science fiction: a paralyzed man punching Barack Obama with a robotic hand; an ALS patient who types only thinking about the keys pressed; a tetraplegic patient who can walk with a slow but natural step.

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

What is Neuralink’s technology?

The company designed a computer chip loaded with electrodes to stitch to the surface of the brain and a robotic device to perform the surgery. Musk expects the devices to be updated regularly.

“I’m sure you wouldn’t want iPhone 1 stuck in your head if iPhone 14 was available,” Musk said at an event in late November 2022, where he predicted Neuralink would begin human testing in six months. .

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

When will human trials begin?

It’s unclear when clinical trials could begin. The brain-computer interface represents one of Musk’s most ambitious bets in his business empire that spans everything from electric cars to rockets that propel humans into space, which has more recently grown to include 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 launched chatbots with large speech models powered by generative AI.

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

Musk and his commitments

Musk’s hectic schedule has him juggling appointments with each of the companies at the same time. He travels across the country on a private jet, visiting his Tesla factories and SpaceX launch sites, participating in Twitter talks and visiting Bay Area headquarters, sometimes all in the same week.

Earlier this month, Musk announced he was appointing advertising executive Linda Yaccarino as CEO of Twitter, relieving him of responsibility for overseeing the social media platform that has fallen into chaos since its acquisition.

With information from The Washington Post

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