Elon Musk’s Neuralink gets FDA approval for in-human study

Neuralink, the neurotechnology startup co-founded by Elon Musk, announced Thursday that it has received approval from the Food and Drug Administration for its procedure. First clinical in human Stady.

Neuralink is building a brain implant called Link, which aims to help severely paralyzed patients control external technologies using only nerve signals. This means that patients with severe degenerative diseases such as ALS can finally regain their ability to communicate with their loved ones by moving cursors and writing with their minds.

“This is the result of the incredible work the Neuralink team has done in close collaboration with the FDA and represents an important first step that will one day allow our technology to help many more people,” the company says. he wrote in a tweet.

The FDA and Neuralink did not immediately respond to CNBC’s request for comment. The extent of the approved trial is unknown. Neuralink said in a tweet that patient recruitment for clinical trials had not yet opened.

Neuralink is part of the emerging brain-computer interface industry, or BCI. BCI is a system that decodes brain signals and translates them into commands for external technologies. Neuralink is perhaps the most well-known name in the space thanks to the high profile of Musk, who is also the CEO of Tesla, SpaceX, and Twitter.

Scientists have been studying BCI technology for decades, and several companies have developed promising systems that they hope to bring to market. But getting FDA approval for a commercial medical device is no small feat — it requires companies to conduct several very thorough rounds of testing and successfully collect safety data.

No BCI company has been able to snatch the final seal of approval from the FDA. But by receiving the green light for a study with human patients, Neuralink is one step closer to the market.

Neuralink’s BCI will require patients to undergo brain surgery. Its system centers around the linker, a small, circular implant that processes and translates nerve signals. The link is attached to a series of thin, flexible threads that are inserted directly into the brain tissue where it detects nerve signals.

Patients with Neuralink devices will learn to control them using the Neuralink app. Patients will then be able to control external mice and keyboards via a Bluetooth connection, according to the The company’s website.

The US Food and Drug Administration (FDA) approval of a human study is an important win for Neuralink after a series of hurdles the company has faced recently. In February, the US Department of Transportation confirmed to CNBC that it had opened an investigation into Neuralink for allegedly unsafely packaging and transporting contaminated hardware. Reuters reported in March that the US Food and Drug Administration denied Neuralink’s request for human trials, reportedly identifying “dozens” of problems the company needed to address.

Neuralink has also come under fire from activist groups for its alleged treatment of animals. Physicians Committee for Responsible Medicine, which advocates against animal testing, He repeatedly called for Musk to release Details about the experiments on monkeys that led to internal bleeding, paralysis, chronic infection, seizures, deterioration of mental health, and death.

A representative for PCRM did not immediately respond to CNBC’s request for comment.

In addition to helping paralyzed patients, experts believe BCIs could one day help treat diseases such as blindness and mental illness. Musk has expressed his intention for Neuralink to explore these future use cases, as well as potential applications for healthy people.

At a “show and tell” recruiting event late last year, Musk claimed he plans to someday receive one of his Neuralink implants himself.

“You could have a Neuralink device implanted right now and you wouldn’t even know,” Musk said at the time. “Actually, I will on one of these demos.”