The Neuralink logo displayed on the phone screen, the silhouette of a paper in the form of a human face, and the binary code displayed on the screen are visible on this multiple illustration photo taken in Krakow on December 10, 2021.
Jakub Porzycki | Nurphoto | Getty’s paintings
Neuralink, a neurotech startup co-founded by Elon Musk, announced on Thursday that it had received approval from the Food and Drug Administration to run first human clinical trial test.
Neuralink is constructing a brain implant called Link to assist severely paralyzed patients control external technologies using only neural signals. Which means patients with serious degenerative diseases like ALS could eventually regain the flexibility to speak with family members by moving their cursors and writing with their minds.
“That is the results of the amazing work of the Neuralink team in close cooperation with the FDA and is a crucial first step that may in the future allow our technology to assist many individuals,” the corporate he wrote in a tweet.
The FDA and Neuralink didn’t immediately reply to CNBC’s request for comment. The extent of the approved study is unknown. Neuralink said in a tweet that patient recruitment for the clinical trial isn’t yet open.
Neuralink is a component of the growing industry of brain-computer interfaces or BCIs. BCI is a system that decrypts brain signals and translates them into commands for external technologies. Neuralink might be essentially the most famous name within the space due to Musk’s high profile, who can also be the CEO of Tesla, SpaceX and Twitter.
Researchers have been studying BCI technology for a long time, and a number of other firms have developed promising systems that they hope to bring to market. But getting FDA approval for a industrial medical device isn’t any easy feat, requiring firms to successfully run several very thorough rounds of testing and collect safety data.
No BCI company has been capable of earn the ultimate FDA seal. But by receiving approval for a human study, Neuralink is one step closer to entering the market.
Neuralink’s BCI would require patients to undergo invasive brain surgery. Its system centers around Link, a small circular implant that processes and translates neural signals. The link is connected to a series of thin, flexible threads inserted directly into the brain tissue, where they detect nerve signals.
Patients with Neuralink devices will learn to manage it using the Neuralink app. Patients will then have the ability to manage external mice and keyboards via a Bluetooth connection company website.
The FDA approval of the human study is a major victory for Neuralink after a series of recent setbacks at the corporate. In February, the U.S. Department of Transportation confirmed to CNBC that it had launched an investigation into Neuralink for allegedly packing and transporting contaminated equipment 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 corporate needed to handle.
Neuralink has also come under fire from activist groups for its alleged treatment of animals. The Medical Committee for Responsible Medicine, which advocates against animal testing, he called on Musk over and over free details of the experiments on monkeys that led to internal bleeding, paralysis, chronic infections, seizures, mental deterioration, and death.
A PCRM representative didn’t immediately reply to CNBC’s request for comment.
Along with helping paralyzed patients, experts imagine that BCIs could in the future help treat diseases akin to blindness and mental illness. Musk expressed his intention for Neuralink to explore these future use cases, in addition to potential uses for healthy people.
During a show-and-tell recruitment event late last yr, Musk even claimed that he plans to in the future receive one among the Neuralink implants himself.
“You possibly can have a Neuralink device implanted straight away and you would not even realize it,” Musk said on the time. “Actually, I will do it in one among these demos.”