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On Thursday, Elon Musk's neurotech startup, Neuralink, announced it has received approval from the Food and Drug Administration (FDA) to begin its first clinical study in humans.
Neuralink has been designing a brain implant called the link with the goal of enabling people with severe paralysis to be able to control external technologies using neural signals. The technology would allow paralyzed individuals to potentially regain some independence while people with severe degenerative diseases like ALS could hopefully regain the ability to communicate with others by essentially 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," Neuralink tweeted about the approved study.
Patient recruitment for the trial is not yet open as Neuralink is still hammering out the details.
Neuralink is at the cutting edge of the emerging brain-computer interface (BCI) industry. A BCI is a computer system that interprets brain signals and translates them into commands for external technologies and devices. Neuralink has gained the most attention in the BCI field given its affiliation with Musk.
While BCI technology has been studied by scientists for decades with several companies developing prototypes and systems, receiving the necessary FDA approval to bring a commercial medical device to market has been no small feat as it requires companies to undergo several rounds of rigorous testing and safety data collection processes.
No company to date has been able to gain the FDA's final approval, but being granted the greenlight for an in-human study is a huge step forward for Neuralink.
The company's BCI will require patients undergo invasive brain surgery to place the Link, a small implant that processes and translates neural signs. A series of think, flexible fibers that are connected to the Link will then be inserted directly into the brain tissue to pick up on neural signals.
An app can then be used by patients with the Link to help them learn to control external mice and keyboards via a Bluetooth connection.
The FDA's approval for the in-human clinical trial comes after several recent setbacks for Neuralink. In February the Department of Transportation confirmed that it had been investigating the company for allegedly packaging and transporting contaminated hardware unsafely, according to CNBC. In March is was reported that Neuralink's application for human trials had been rejected by the FDA citing "dozens" of issues that needed to be addressed before approval could be granted.
As expected, the company has also faced scrutiny and criticism from animal rights groups. The Physician's Committee for Responsible Medicine, which advocates against animal testing, has continuously called for the release of details about Neuralink experiments that have allegedly left monkeys with paralysis, seizures, internal bleeding, chronic infections, declining psychological health, and even death.
Despite Neuralink's setbacks, experts are already looking to other ailments that could potentially be treated by BCIs in the future including blindness and mental illness. Musk has indicated that the company intends to expand into such areas in the future as well as potentially into uses for healthy individuals.
Musk has also said that he intends to be fitted with a Neuralink implant at some point. "You could have a Neuralink device implanted right now and you wouldn't even know," Musk said during a "show and tell" event for the company last year.
"In face, in of these demos, I will," he said.
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