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Elon Musk’s Neuralink Receives FDA Approval for Human Trial

Elon Musk’s Neuralink Receives FDA Approval for Human Trial

The Neuralink logo displayed on a phone screen, a paper silhouetted in the shape of a human face, and a binary code displayed on a screen can be seen in this multi-exposure illustrative photo taken on December 10, 2021 in Krakow, Poland.

Jakub Porzycki | Nurphoto | Getty Images

Neuralink, the neurotech startup co-founded by Elon Musk, announced Thursday that it has received approval from the Food and Drug Administration to conduct its first human clinical trial.

Neuralink is building a brain implant called Link, designed to help patients with severe paralysis control external technologies using only neural signals. This means that patients with severe degenerative diseases like ALS could eventually be able to communicate with loved ones again by moving the cursor and typing with their minds.

“This is the result of the incredible work of 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 wrote in a tweet.

The FDA and Neuralink did not immediately respond to CNBC’s request for comment. The scope of the approved trial is unknown. Neuralink said in a tweet that patient recruitment for its clinical trial 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 technologies. Neuralink is perhaps the most recognizable name in the industry 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 plan to bring to market. But getting FDA approval for a commercial medical device is no easy task — it requires companies to successfully complete multiple, extremely thorough rounds of testing and data security collection.

No BCI company has been able to earn the FDA’s final seal of approval. But Neuralink is one step closer to commercialization by approving a study in human patients.

Neuralink’s BCI requires patients to undergo invasive brain surgery. His system revolves around the Link, a small circular implant that processes and translates neural signals. The link is attached to a series of thin, flexible threads that are inserted directly into the brain tissue, where it picks up neural signals.

Patients with Neuralink devices learn to control them using the Neuralink app. Patients can then control external mice and keyboards over a Bluetooth connection, according to the company’s website.

The FDA’s approval of a human trial is a significant victory for Neuralink after a series of recent hurdles at the company. In February, the US Department of Transportation confirmed to CNBC that it was investigating Neuralink for allegedly unsafe packaging and shipment of contaminated hardware. Reuters reported in March that the FDA had denied Neuralink’s application for human testing, reportedly naming “dozens” of issues the company needed to address.

Neuralink has also come under criticism from activist groups for its alleged treatment of animals. The Physician’s Committee for Responsible Medicine, which opposes animal testing, has repeatedly urged Musk to release details of experiments on monkeys that resulted in internal bleeding, paralysis, chronic infection, seizures, deterioration in mental health, and death.

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

Experts believe that BCIs could not only help paralyzed patients, but could also help treat conditions like 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” recruitment event late last year, Musk even claimed he plans to one day receive one of Neuralink’s implants himself.

“You could have a Neuralink device implanted right now without even realizing it,” Musk said at the time. “In fact, I’m going to do that in one of these demos.”

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