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 multiple exposure illustration photo taken on Dec. 10, 2021 in Krakow, Poland.
Jacob Porzycki Norphoto Getty Images
Co-founded Neuralink, a neurotech startup Elon Muskannounced Thursday that it had received approval from the Food and Drug Administration to operate it First in-human clinical study.
Neuralink is developing a brain implant called Link, which aims to help patients with severe paralysis 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 said. 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 the emerging segment Brain-computer interface, or BCI, Art. A BCI is a system that Decodes brain signals and translates them into external technology commands. Neuralink is probably the most recognizable name in the space thanks to its high profile muskWho is its CEO TeslaSpaceX and Twitter.
Scientists have been studying BCI technology for decades and several companies have developed it promising system 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 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 directly 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 Company 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 Neuralink for allegedly packaging and transporting corrupted hardware in an unsafe manner. Reuters reported In March, 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 attack from activist groups for its alleged treatment of animals. The Physicians Committee for Responsible Medicine, which advocates against animal testing, Called Kasturi repeatedly liberation Details about the exam on monkeys resulting in internal bleeding, paralysis, chronic infections, seizures, impaired 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 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 plans to get an implant of Neuralink someday.
“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.”
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