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 can be seen in this multiple-exposure illustration photo taken in Krakow, Poland, on December 10, 2021.
Jakub Porzycki | NurPhoto | Getty Images
Neuralink, the neurotech startup co-founded by Elon Musk, announced on Thursday that it has received approval from the Food and Drug Administration for its operations. First in-human clinical Study.
Neuralink is building a brain implant called Link, which aims to help patients with severe paralysis control external technologies using only nerve signals. This means that patients with severe degenerative diseases such as ALS may finally regain the ability to communicate with their loved ones and type 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 more 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 accepted test is not known. 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. BCI is a system that interprets 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 getting FDA approval for a commercial medical device is no small task—it requires companies to successfully conduct several extremely intensive rounds of testing and data safety collection.
No BCI company has been successful in obtaining the FDA’s final seal of approval. But by getting the green light for a study with human patients, Neuralink is one step closer to market.
Neuralink’s BCI requires patients to undergo invasive brain surgery. Its system is centered around the Link, a small circular implant that processes and translates nerve signals. The links are attached to a series of thin, flexible threads inserted directly into brain tissue where they detect nerve signals.
Patients with a Neuralink device will learn to control it using the Neuralink app. According to the company’s website, patients will be able to control external mice and keyboards via a Bluetooth connection.
The FDA’s approval for the human study is a significant win 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. Reuters reported in March that the FDA had rejected Neuralink’s application for human trials, and outlined “dozens” of issues the company needed to address.
Neuralink has also come under fire from activist groups for its alleged treatment of animals. Physicians Committee for Responsible Medicine, which advocates against animal testing Has repeatedly called Musk To release details about experiments conducted on monkeys that resulted in internal bleeding, paralysis, chronic infections, seizures, deterioration in psychological health, and death.
A representative for PCRM did not immediately respond to CNBC’s request for comment.
In addition to helping paralyzed patients, experts believe BCIs could someday help treat diseases 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 also claimed that he plans to someday receive one of Neuralink’s implants himself.
Musk said at the time, “You could have a Neuralink device implanted right now and you wouldn’t even know it.” “Actually, in one of these demos, I would.”
