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In-Human Study of Elon Musk’s Neuralink Receives FDA Approval

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

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

Neuralink, the neurotech startup co-founded by Elon Musk, has received approval from the Food and Drug Administration (FDA) to conduct its first in-human clinical study. The company is building a brain implant called the Link, which aims to help patients with severe paralysis control external technologies using only neural signals. Neuralink’s BCI will require patients to undergo invasive brain surgery as the Link processes and translates neural signals. Patients will then be able to control external mice and keyboards through a Bluetooth connection. The FDA’s approval for an in-human study is a significant win for Neuralink after a series of recent hurdles at the company.

FAQs:

What is Neuralink?
Neuralink is a neurotech startup co-founded by Elon Musk.

What is the Link?
The Link is a small circular implant that processes and translates neural signals.

What is BCI?
BCI stands for brain-computer interface, which is a system that deciphers brain signals and translates them into commands for external technologies.

What is the purpose of Neuralink’s brain implant?
Neuralink’s brain implant aims to help patients with severe paralysis control external technologies using only neural signals.

What does the FDA approval mean for Neuralink?
The FDA’s approval for an in-human study is a significant win for Neuralink after a series of recent hurdles at the company. No BCI company has managed to clinch the FDA’s final seal of approval, but by receiving the go-ahead for a study with human patients, Neuralink is one step closer to market.

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

In-Human Study of Neuralink Receives FDA Clearance, Commences under Elon Musk’s Direction

Neuralink, the neurotech startup co-founded by Elon Musk, announced on Thursday that it has received approval from the Food and Drug Administration to conduct 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 patients with severe degenerative diseases like ALS could 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 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 extent of the approved trial is not known and patient recruitment for its clinical trial is not open yet, according to Neuralink. The FDA and Neuralink did not immediately respond to CNBC’s request for comment.

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.

Neuralink’s BCI will require patients to undergo invasive brain surgery. Its system centers around the 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 neural signals.

The FDA’s approval for an in-human study is a significant win for Neuralink after a series of recent hurdles at the company. In February, the U.S. 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 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, has repeatedly called on Musk to release details about experiments on monkeys that had resulted in internal bleeding, paralysis, chronic infections, seizures, declining psychological health, and death. A representative for PCRM did not immediately respond to CNBC’s request for comment.

In addition to helping patients with paralysis, experts believe BCIs could someday help treat maladies like blindness and mental illness. Musk has expressed his intent for Neuralink to explore these future use cases, as well as potential applications for healthy people.

At a “show and tell” recruitment event late last year, Musk even claimed he plans to someday receive one of Neuralink’s implants himself. “You could have a Neuralink device implanted right now and you wouldn’t even know,” Musk said at the time. “In fact, in one of these demos, I will.”

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