by Neuralink, the neurotech startup co-founded by Elon Musk, announced Thursday that it has received approval from the Food and Drug Administration to launch its first in-human clinical study.
Neuralink is building a brain implant called the Link, which aims to help patients with severe paralysis control external technologies using only neural signals. This means that patients with serious 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 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 size of the approved trial 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 best known name in the 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 plan to bring to market. But getting FDA approval for a commercial medical device is no small feat – it requires companies to successfully complete a number of extremely thorough rounds of testing and collect data on safety.
No BCI company has succeeded in obtaining the FDA’s final seal of approval. But getting the green light for a human patient study brings Neuralink one step closer to market.
Neuralink’s BCI requires patients to undergo invasive brain surgery. The system revolves around the Link, a small round implant that processes and translates neural signals. The Link is connected to a series of thin, flexible wires that are inserted directly into brain tissue, where they detect neural signals.
Patients with Neuralink devices will learn to operate them 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.
FDA approval for a human trial 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 shipping compromised hardware in an unsafe manner. Reuters reported in March that the FDA rejected Neuralink’s application for human trials, and reportedly outlined “dozens” of issues the company needed to address.
Neuralink has also come under fire from activist groups for its alleged treatment of animals. The Physician’s Committee for Responsible Medicine, which advocates against animal testing, repeatedly appealed to Musk to release details of experiments on monkeys that had resulted in internal bleeding, paralysis, chronic infections, seizures, declining mental health and death.
A PCRM representative did not immediately respond to CNBC’s request for comment.
In addition to helping patients with paralysis, experts believe BCIs may one day help treat illnesses such as blindness and mental illness. Musk has stated his intention that Neuralink will explore these future use cases, as well as potential applications for healthy humans.
In fact, at a show and tell recruiting event late last year, Musk claimed he planned to receive one of Neuralink’s implants himself one day.
“You could have a Neuralink device implanted right now and you wouldn’t even know it,” Musk said at the time. “In fact, I will in one of these demos.”
This article was originally published on NBCNews.com
