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 it has regulatory approval to conduct the first clinical trial of its experimental device in humans.

Approval from the US Food and Drug Administration would mark a milestone for the company, which has developed a device that is surgically inserted into the brain by a robot and is able to decode brain activity and link it to computers. Until now, the company has only conducted research in animals.

“We are pleased to announce that we have received FDA approval to initiate our first human clinical trial!” neural link announced on Twitter, called it “an important first step that will allow our technology to help many people one day.” Musk retweeted the post and congratulated his team.

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

Musk has previously touted premature regulatory approval. In 2017, he wrote on Twitter that his tunnel company, The Boring Company, has received “verbal government 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 that no formal action had been taken 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 company with offices in Fremont, California, 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 the brain-computer interface, where scientists and engineers are developing electronic implants that would decode and transmit brain activity to computers. Such technology, which has been decades in the making, has the potential to restore function to people with paralysis and debilitating conditions such as amyotrophic lateral sclerosis.

Companies like Blackrock Neurotech and Synchron have already implanted their devices in humans for clinical trials, and at least 42 people worldwide have had brain computer implants. Such devices have enabled feats that once belonged to the realm of science fiction: a paralyzed man fist-punching Barack Obama with a robotic hand; a patient with ALS types by thinking about keystrokes; a tetraplegic patient who manages to walk with a slow but natural stride.

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

“We want to exceed the performance of healthy people with our technology,” says 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 that is sewn into the surface of the brain, and a robot to perform the surgery. Musk foresees that the devices can be upgraded regularly.

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

Although an important milestone, a human clinical trial for the device does not guarantee regulatory or commercial success. Neuralink and others will undoubtedly face intense scrutiny by the FDA about whether their devices are safe and reliable, in addition to ethical and security questions raised by a technology that could provide a cognitive benefit to people with an implant.

When will human clinical trials begin?

It’s unclear when clinical trials could begin.

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

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

Meanwhile, in recent months, he’s spent much of his time on Twitter, the social media company he bought for $44 billion last year and promised to restore “free speech.”

Musk’s hectic schedule causes him to juggle commitments to each of the companies at once. He travels the country on a private jet, visits its Tesla factories and SpaceX launch sites and speaks pledges for Twitter and visits the headquarters in the Bay Area – sometimes all in the same week. Musk announced earlier this month that he would appoint advertising executive Linda Yaccarino as CEO of Twitter, absolving some of the responsibility for overseeing the social media platform that has been thrown into chaos since its acquisition last year.

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