Elon Musk’s Neuralink gets FDA approval for in-human study

The Neuralink logo displayed on the phone screen, the silhouette of a sheet of paper with a human face and the binary code displayed on the screen are featured in this multiple exposure illustration taken in Krakow, Poland on the 10th of May. 12 year 2021.

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Neuralink, a neurotechnology startup co-founded by Elon Muskannounced Thursday that it has received Food and Drug Administration approval to proceed first clinical on humans learn.

neural link is building a brain implant called Link, which aims to help severely paralyzed patients control external technologies using only nerve signals. This means that patients with serious degenerative diseases like ALS can eventually regain the ability to communicate with loved ones by moving the cursor and typing with their mind.

“This is the result of the incredible work of 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. ty wrote in a tweet.

The FDA and Neuralink did not immediately respond to CNBC’s request for comment. The extent of the approved trial is not known. Neuralink said in a tweet that patient recruitment for the clinical trial is not open yet.

Neuralink is part of the rise brain-computer interface, or BCI, industry. BCI is a system decode brain signals and translate them into commands for external technologies. Neuralink is probably the most famous name in the space thanks to its high profile muskis also the CEO of TeslaSpaceX and Twitter.

Scientists have been studying BCI technology for decades and several companies have developed Promising system that they hope to bring to market. But getting FDA approval for a commercial medical device is no easy task — it requires companies to successfully conduct several rounds of testing and collect extreme safety data. thorough period.

No BCI company has earned the FDA’s final seal of approval. But by continuing to work with human patients, Neuralink has moved one step closer to market.

Neuralink’s BCI will require the patient to undergo invasive brain surgery. Its system revolves around Link, a small circular implant that processes and translates nerve signals. The link is connected to a series of thin, flexible fibers that are inserted directly into brain tissue where they detect nerve signals.

Patients with a Neuralink device will learn how to control the device using the Neuralink app. The patient will then be able to control an external mouse and keyboard via a Bluetooth connection. The company’s web site.

FDA approval for a human study is an important victory for Neuralink after a series of recent roadblocks at the company. In February, the U.S. Department of Transportation confirmed to CNBC that it had opened an inquiry to Neuralink for allegedly packaging and transporting contaminated 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 been criticized by activist groups for its alleged treatment of animals. The Physicians’ Responsible Medicine Committee, which advocates against animal testing, has repeatedly called on Musk release details of the experiment in monkeys resulted in internal bleeding, paralysis, chronic infection, convulsions, impaired psychological well-being, and death.

A representative for PCRM did not immediately respond to CNBC’s request for comment.

In addition to helping paralyzed patients, experts believe that BCI could one day help treat conditions such as blindness and mental illness. Musk has expressed his intention to let Neuralink explore these future use cases, as well as potential applications for healthy people.

At an “show and tell” recruiting event late last year, Musk even announced that he plans to one day receive one of Neuralink’s implants himself.

“You can implant a Neuralink device right now and you won’t even know it,” Musk said at the time. “Actually, I’m going to do one of these demos.”


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