Elon Musk’s Neuralink Gets FDA Approval for Human Trials: What You Need to Know

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Elon Musk’s brain implant company, Neuralink, announced Thursday night that it has received regulatory approval to conduct the first clinical trial of its device in humans.

The U.S. Food and Drug Administration’s approval marks a milestone for the company, which has developed a device that can be surgically inserted into the brain by a robot to decode brain activity and connect it to a computer. The company has so far only conducted studies in animals.

We are pleased to share that we have received FDA clearance to begin our first human clinical study. Neuralink announced on Twitter that it is an important first step that one day our technology will help many people. Musk retweeted the post and congratulated the team.

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

Musk has previously touted regulatory approval prematurely. In 2017, he wrote on Twitter that his own tunneling company, The Boring Company, had verbal approval from the government to build an underground hyperloop from New York to Washington, DC. Officials at the time did not provide direct confirmation of Musk’s claims, and it was clear that no formal steps had been taken to approve such a project.

A race with Elon Musk to embed chips in people’s brains

Founded in 2016, Neuralink is privately held and operates out of sprawling under-construction campuses outside of Fremont and Austin, California. The company has more than 400 employees and has raised at least $363 million, according to the data provider PitchBook.

With Musk’s backing, Neuralink has drawn extraordinary resources and investor attention to a field known as brain-computer interfaces, electronic implants that allow scientists and engineers to decode brain activity and communicate it to computers. is developing. Such techniques have been under investigation for decades and have the potential to restore function in people with debilitating conditions such as paralysis and amyotrophic lateral sclerosis.

Already, companies such as Blackrock Neurotech and Synchron have implanted their devices in humans for clinical trials, and at least 42 people worldwide have received brain computer implants. Such devices have enabled feats that once belonged to the realm of science fiction. A paralyzed man uses a robotic hand to punch Barack Obama. ALS patient thinking about keystrokes and typing. A quadriplegic patient managed to walk with a slow but natural stride.

While most companies looking to commercialize brain implants focus on people with medical needs, Neuralink has bigger ambitions to develop devices that not only restore but enhance human function.

Neuralink tweeted in April that he wanted his technology to surpass the performance of able-bodied people.

Elon Musk Says He’s About Six Months Until Neuralink Experiments on Humans

What is Neuralinks Brain Chip Technology?

The company has designed a computer chip with electrodes that are sewn into the surface of the brain and a robotic device that performs the surgery. Musk assumes the device can be upgraded on a regular basis.

If the iPhone 14 hits the market, the iPhone 1 should be on your mind, Musk said at an event in late November, predicting that Neuralink’s human testing could begin within six months.

While an important milestone, human clinical trials of the device do not guarantee regulatory or commercial success. In addition to the ethical and safety issues raised by technology that could give implant wearers a cognitive advantage, Neuralink and other companies face the rigorous FDA scrutiny of whether their devices are safe and reliable. You will inevitably face scrutiny.

When will human clinical trials begin?

It’s unclear when clinical trials will begin.

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

Earlier this year, Musk founded X.AI, a company aimed at competing with Microsoft and Google after they announced large-scale language-model chatbots that could answer a wide range of queries.

Meanwhile, in recent months, he has spent much of his time at Twitter, the social media company he bought last year for $44 billion on promises to restore free speech.

Musk’s hectic schedule keeps him fulfilling his commitments to companies at the same time. He travels the country on a private jet, visits Tesla factories and SpaceX launch sites, attends speaking engagements on Twitter, and sometimes visits the company’s Bay Area headquarters in the same week. Earlier this month, Musk announced that advertising chief Linda Yaccarino would be named CEO of Twitter, relieving some of the responsibilities of overseeing the social media platform, which has been in turmoil since its acquisition last year. bottom.

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