Elon Musk’s Brain Implant Company Neuralink Announces FDA Approval for Human Clinical Study

The neurotechnology startup Neuralink, co-founded by Elon Musk, was informed Thursday by the U.S. Food and Drug Administration. First human clinical study.

Neuralink is building a brain implant called Link. It is intended to allow patients with severe paralysis to control external technology using only nerve signals. This means that patients with severe degenerative diseases like ALS will eventually regain the ability to communicate with their loved ones by moving the cursor or typing with their heads.

“This is the result of a great job by the Neuralink team working closely with the FDA and represents an important first step that will one day allow our technology to help many people,” the company said. ing. wrote in a tweet.

The FDA and Neuralink did not immediately respond to CNBC’s request for comment. The extent of the approved trials is unknown. In a tweet, Neuralink said it had not yet begun recruiting patients for clinical trials.

Neuralink is part of the emerging Brain Computer Interface (BCI) industry. BCI is a system that decodes brain signals and translates them into commands for external technology. Neuralink is probably the best-known name in the space, thanks to the high profile of Musk, who is also his CEO of Tesla, SpaceX and Twitter.

Scientists have been studying BCI technology for decades and have developed promising systems that several companies hope to bring to market. However, obtaining FDA approval for a marketed medical device is not an easy task. Companies have to go through several rounds of very thorough testing and data security collection in order.

No BCI company has achieved the FDA’s final seal of approval. But with the green light for research in human patients, Neuralink is one step closer to the market.

Neuralink’s BCI requires patients to undergo invasive brain surgery. Its system revolves around Link, a small circular implant that processes and transforms nerve signals. The links are connected to a series of thin, flexible threads inserted directly into brain tissue, where nerve signals are detected.

Patients with Neuralink devices will learn how to control their devices using the Neuralink app. The patient will be able to control an external mouse and keyboard through her Bluetooth connection, according to the company. company website.

After a string of recent setbacks at Neuralink, the FDA approval of human studies is a big win for Neuralink. In February, the U.S. Department of Transportation confirmed to CNBC that it had opened an investigation into Neuralink for allegedly unsafely packaging and shipping contaminated hardware. Reuters reported in March that the FDA had rejected Neuralink’s application for human trials, outlining “dozens” of issues the company would need to address.

Neuralink has also come under fire from activist groups for working with animals. The Physicians Committee for Responsible Medicine, which advocates against animal testing, Called Mr. Musk repeatedly release Experiment details Monkeys with internal bleeding, paralysis, chronic infections, seizures, poor mental health and death were included.

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

Beyond helping paralyzed patients, experts believe BCIs could one day help treat ailments such as blindness and mental illness. Musk expressed his intention for Neuralink to explore these future use cases and potential applications in healthy humans.

At a “Show and Tell” recruitment event late last year, Musk even claimed that he would one day get a Neuralink implant.

“If we had a Neuralink device implanted right now, we wouldn’t even know it,” Musk said at the time. “Actually I do in one of these demos.”