Elon Musk’s Brain Implant Company Neuralink Announces FDA Approval of Human Clinical Study
The Neuralink logo displayed on a phone screen, a paper silhouette shaped like a human face, and a binary code displayed on a screen are seen in this illustrative multiple exposure photo taken in Krakow, Poland, on December 10, 2021.
Jakub Porzycki | Nurfoto | fake images
Neuralink, the neurotech startup co-founded by Elon Musk, announced Thursday that it has received approval from the Food and Drug Administration to carry out its first human clinic study.
Neuralink is building a brain implant called Link, which aims to help severely paralyzed patients control external technologies using only neural signals. This means that patients with severe degenerative diseases such as ALS could eventually regain their ability to communicate with their loved ones by moving cursors and typing with their minds.
“This is the result of incredible work done 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. 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 the recruitment of patients for its clinical trial is 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 best-known name in 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 receiving FDA approval for a commercial medical device is no easy task: it requires companies to successfully conduct multiple rounds of testing and extremely thorough data safety collection.
No BCI company has yet achieved the final seal of approval from the FDA. But by getting the go-ahead for a study with human patients, Neuralink is one step closer to market.
Neuralink’s BCI will require patients to undergo invasive brain surgery. His system centers around 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 to control it 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 approval for a human study is a major 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 contaminated hardware in an unsafe manner. trendswire reported in March that the FDA had rejected Neuralink’s application for human trials, reportedly outlining “dozens” of issues the company needed to address.
Neuralink has also been criticized by activist groups for its alleged treatment of animals. The Physicians Committee for Responsible Medicine, which advocates against animal testing, has repeatedly called Musk to release details about experiments on monkeys that 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.
In addition to helping patients with paralysis, experts believe that BCIs could one day help treat conditions 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 even claimed that he plans to one day receive one of Neuralink’s implants.
“You could have a Neuralink device implanted right now and you wouldn’t even know it,” Musk said at the time. “In fact, in one of these demos, I will.”