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 in-human clinical study.
Neuralink is developing a brain implant called Link. Which aims to help paralyzed patients control external . Technology using only neural signals. This means patients with severe degenerative diseases like . ALS can finally regain the ability to communicate with loved ones by moving the cursor and typing with their mind.
“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 wrote in a tweet.
The FDA and Neuralink did not immediately respond to CNBC’s requests for comment. The amount of trial allowed 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 decodes brain signals and translates them into commands for external technology. Neuralink is the best-known name in the space thanks to the high profile of Tesla, SpaceX and Twitter CEO Musk.
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 pass several very thorough rounds of testing and data security collection.
No BCI company has ever received the FDA’s final seal of approval. But by moving to research in human patients, Neuralink is one step closer to market.
Neuralink’s BCI patients have to undergo invasive brain surgery. Its system centers around the Link, a small circular implant that processes and translates nerve signals. The link is attached to a series of thin, flexible threads inserted into the brain tissue where they detect neural signals.
Patients with the Neuralink device will learn to control it using the Neuralink app. Patients will then be able to control external mice and keyboards via . Bluetooth connectivity, according to the company’s website.
The FDA’s approval for an in-human study is a significant win for Neuralink after a series of recent setbacks for 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 problems. The company needed to address.
Neuralink has also come under attack from activist groups for its alleged treatment of animals. The Physicians Committee for Responsible Medicine, which advocates against animal testing. Has called on Musk to disclose details of experiments on monkeys. that resulted in internal bleeding, paralysis, chronic infections, seizures, decreased psychological health and death.
A representative for PCRM did not immediately respond to CNBC’s request for comment.
Besides to helping paralyzed patients. Experts believe BCI may one day help treat diseases such as blindness and mental illness. Musk expressed his intention for Neuralink to explore these future use cases. As well as potential applications for healthy humans.
At a “show and tell” recruiting event late last year. Musk even claimed he was planning to get an implant of Neuralink himself.
“You could deploy a NeuraLink device right now and you wouldn’t even know,” Musk said at the time. “Actually, in one of these demos, I will.”