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 multi-exposure illustration photo taken in Krakow, Poland on December 10, 2021 .
Jakub Porzycki | Nurfoto | Getty Images
Neuralink, the neurotechnology startup co-founded by Elon Musk, announced on Thursday that it has received approval from the Food and Drug Administration to conduct its first human clinic to 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 may 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. wrote in a tweet.
The FDA and Neuralink did not immediately respond to CNBC’s request for comment. The extent of the approved study is not known. Neuralink said in a tweet that patient recruitment 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 most recognizable name in the space thanks to the high profile of Musk, who is also 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 feat — it requires companies to successfully conduct several extremely thorough rounds of testing and safety data collection.
No BCI company has been able to obtain the final seal of approval from the FDA. But by receiving approval for a human patient study, Neuralink is one step closer to market.
Neuralink’s BCI will require patients to undergo invasive brain surgery. His system revolves around the Link, a small circular implant that processes and translates neural signals. 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 through a Bluetooth connection, according to the company’s website.
FDA approval for a 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 unsafely packaging and transporting contaminated hardware. Reuters reported in March that the FDA rejected Neuralink’s application for human trials and outlined “dozens” of issues the company needed to address.
Neuralink has also been criticized by activist groups for its alleged treatment of animals. The Medical Committee for Responsible Medicine, which advocates against animal testing, repeatedly called out Musk to release details about experiments on monkeys that resulted in internal bleeding, paralysis, chronic infections, seizures, declining 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 stated that he plans to someday receive one of Neuralink’s implants himself.
“You could have a Neuralink device implanted right now and not even know it,” Musk said at the time. “Actually, on one of these demos, I will.”