Elon Musk’s Neuralink Receives FDA Approval for Human Trials: What Do You Know

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

The approval by the US Food and Drug Administration would mark a milestone for the company, which is developing a device that will be surgically inserted into the brain by a robot and capable of decoding brain activity and linking it to computers. To date, 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 study!” Neuralink Advertise on TwitterHe called it “an important first step that will one day allow our technology to help many more people”. musk Retweeted Post, congratulate his team.

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

Musk has prematurely promoted regulatory approval before. In 2017, he wrote on Twitter that his company, The Boring Company, had received “verbal government approval” for an underground hyperloop from New York to DC. Officials at the time did not provide any direct confirmation of Musk’s claim – and it was clear that no official measures 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 privately owned 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 backing, Neuralink has brought extraordinary resources — and investor interest — to a field known as the brain-computer interface, where scientists and engineers develop electronic devices that decode brain activity and transmit it to computers. This 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 like Blackrock Neurotech and Synchron have implanted their devices in people for clinical trials, and at least 42 people globally have implanted brain computers. Such devices enabled feats that once belonged to the realm of science fiction: a paraplegic man slamming into Barack Obama’s fist with his robotic hand; A patient with ALS types by thinking of keystrokes; A quadriplegic patient can walk at a slow but normal pace.

While most companies seeking to commercialize brain implants focus on those with medical needs, Neuralink has larger ambitions: to create a device that not only restores human function, but also enhances it.

“We want to go beyond capable human performance with our technology,” Neuralink chirp in April.

Elon Musk says Neuralink is about six months away from human trials

What is Neuralink’s brain chip technology?

The company designed an electrode-loaded computer chip to be sewn into the surface of the brain, and a robotic device to perform the surgery. Musk envisions that hardware can be upgraded 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 expected Neuralink to begin human trials within six months.

Although an important milestone, conducting a clinical trial of his device in humans does not guarantee regulatory or commercial success. Neuralink and others are bound to face intense scrutiny from the Food and Drug Administration (FDA) to ensure that their devices are safe and reliable, as well as to confront ethical and security questions posed by a technology that could give a cognitive advantage to those with an implant.

When will human clinical trials begin?

It is not clear when clinical trials may begin.

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

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

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

Musk’s hectic schedule has him juggling commitments to every company one at a time. He travels the country on a private jet, visits Tesla’s factories and SpaceX launch sites and takes part in speaking engagements on Twitter and visits to its Bay Area headquarters — sometimes all in the same week. Musk announced earlier this month that he had appointed advertising director Linda Iaccarino as CEO of Twitter, relieving him of some responsibility for overseeing the social media platform that has been mired in chaos since taking office last year.

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