The Neuralink logo displayed on a phone screen, a paper silhouette in the shape of a human face and a binary code displayed on the screen are seen in this multiple exposure illustration photo taken in Krakow, Poland, on December 10, 2021.

Yakub Pazhytsky | Nurphoto | Getty Images

Neuralink, the neurotechnology startup co-founded by Elon Musk, announced Thursday that it has received approval from the Food and Drug Administration to conduct the first wedge research.

Neuralink is creating a brain implant called Link that aims to help patients with severe paralysis control external technology using only neural signals. This means that patients with severe degenerative diseases such as ALS could eventually regain their ability to communicate with loved ones by moving cursors and typing with their minds.

“This is the result of incredible work by the Neuralink team in close collaboration with the FDA and represents an important first step that will one day allow our technology to help many people,” the company said in a statement. tweeted.

The FDA and Neuralink did not immediately respond to CNBC’s request for comment. The scope of the approved trial is unknown. In its tweet, Neuralink reported that the recruitment of patients for participation in clinical trials is not yet open.

Neuralink is part of the burgeoning brain-computer interface, or BCI, industry. A BCI is a system that decodes brain signals and translates them into commands for external technology. Neuralink is perhaps the most famous 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 easy task—it requires companies to successfully complete several extremely thorough rounds of testing and safety data collection.

No BCI company has been able to get the FDA’s final seal of approval. But with approval for a patient trial, Neuralink is one step closer to market.

Neuralink’s BCI will require patients to undergo invasive brain surgery. Its system centers around the Link, a small, circular implant that processes and transmits nerve signals. Link is connected to a series of thin, flexible filaments inserted directly into brain tissue, where they detect nerve signals.

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

The FDA’s human trial approval is a major win for Neuralink after a series of recent setbacks for the company. In February, the US Department of Transportation confirmed to CNBC that it had opened an investigation into Neuralink for allegedly unsafely packaging and transporting infected equipment. In March, Reuters reported that the FDA rejected Neuralink’s application for human trials and reportedly outlined “dozens” of issues the company needs to address.

Neuralink has also come under fire from activist groups for its alleged treatment of animals. The Physicians Committee for Responsible Medicine, which opposes animal testing, repeatedly appealed to Musk publish details of experiments on monkeys that resulted in internal bleeding, paralysis, chronic infections, seizures, impaired psychological health, and death.

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

In addition to helping patients with paralysis, experts believe that BCI could one day help treat diseases such as blindness and mental illness. Musk expressed Neuralink’s intention to explore these future use cases, as well as potential applications for healthy humans.

At a show-and-tell hiring event late last year, Musk even said he plans to get one of the Neuralink implants himself someday.

“You could implant a Neuralink device right now and you wouldn’t even know,” Musk said at the time. “Actually, one of these demonstrations will be me.”

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