Elon Musk’s Neuralink gets FDA approval for human study


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

Jakub Porzycki | Nurphoto | Getty Images

Neuralink, the neurotech startup co-founded by Elon Musk, announced Thursday that it has received Food and Drug Administration approval to conduct its first in man clinic study.

Neuralink is building a brain implant called Link, which aims to help patients with severe paralysis control external technologies using only neural signals. This means that patients with serious degenerative diseases like ALS could eventually regain their ability to communicate with loved ones by moving sliders and tapping with their minds.

“This is the result of incredible work 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. 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 not known. Neuralink said in a tweet that patient recruitment for its clinical trial was not yet open.

Neuralink is part of the emerging brain-computer interface, or BCI, industry. A BCI is a system that deciphers brain signals and translates them into commands for external technologies. Neuralink is perhaps the most well-known name in space thanks to the notoriety 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 receiving FDA approval for a commercial medical device is no small feat – it requires companies to complete multiple rounds of extremely thorough testing and collect safety data.

No BCI company has managed to earn the final seal of approval from the FDA. But by receiving the green light for a study in human patients, Neuralink is getting a little closer to the market.

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

Patients with Neuralink devices will learn how to control it using the Neuralink app. Patients will then be able to control external mice and keyboards via a Bluetooth connection, depending on the Company Website.

FDA approval for a human study 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 had opened an investigation into Neuralink for allegedly packaging and transporting hazardously contaminated material. Reuters reported in March that the FDA had rejected Neuralink’s application for human trials and reportedly described “dozens” of issues the company needed to address.

Neuralink has also been criticized by activist groups for its alleged treatment of animals. The Physician’s Committee for Responsible Medicine, which campaigns against animal testing, appealed to Musk several times release experience details on monkeys which had resulted in internal bleeding, paralysis, chronic infections, seizures, deterioration of psychological health and death.

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

As well as helping patients with paralysis, experts believe BCIs could one day 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.

During a “show and tell” recruiting event late last year, Musk even claimed that he planned to one day receive one of Neuralink’s implants himself.

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

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