Elon Musk's Neuralink gets approval for human trials

Neuralink is developing a brain implant called Link. The goal of Link is to help severely paralyzed patients use nerve signals to control external devices. That means patients with serious degenerative diseases like ALS (amyotrophic lateral sclerosis) could regain the ability to communicate with loved ones by moving a cursor and typing with their thoughts.

Elon Musk's Neuralink wins big as it gets to conduct clinical research on humans. (Photo: Reuters)

Neuralink said on Twitter that the licensing is the first step in its journey to allowing its technology to help more people. It’s unclear how extensive the trial will be, according to CNBC . Neuralink has also not yet begun recruiting patients for its clinical trials.

Neuralink is part of the brain-computer interface (BCI) industry. BCI systems decode brain signals and “translate” them into commands for external technology. Neuralink is perhaps the most well-known name thanks to the profile of Musk, who is also the CEO of Tesla, SpaceX, and Twitter.

Scientists have been researching BCI technology for decades. Several companies have developed promising systems that they hope to bring to market. But getting FDA approval for a commercial medical device is no easy feat. It requires companies to successfully conduct rigorous testing and collect safety data.

No BCI company has yet received the final “yes” from the FDA. Still, getting permission to conduct clinical trials on humans would put Neuralink one step closer to market.

Neuralink’s BCI technology requires patients to undergo invasive brain surgery. Its system revolves around Link, a small, circular implant that processes and “interprets” neural signals. Link connects to a series of thin, flexible threads that are inserted directly into brain tissue where neural signals are detected.

Patients implanted with Neuralink’s device will learn how to control it through the Neuralink app. They will then be able to control a mouse and keyboard via Bluetooth, according to the startup’s website.

The FDA approval is a major victory for Neuralink after a series of recent setbacks. In February, the U.S. Department of Transportation confirmed that it was investigating the company for allegedly unsafe packaging and shipping of contaminated hardware. A month later, Reuters reported that the FDA had rejected the startup’s application for human testing, citing dozens of issues that needed to be addressed.

Neuralink has also been criticized by animal rights groups, who have called on Musk to disclose that experiments on monkeys have resulted in external bleeding, paralysis, chronic infections, seizures, mental health problems, and death.

In addition to helping paralyzed patients, experts believe that BCIs will one day help treat conditions like blindness and mental health. Musk said Neuralink will explore these cases in the future. At an event late last year, he even announced that he would personally implant a Neuralink device.

(According to CNBC)

Elon Musk's company killed 1,500 animals while testing its Neuralink brain chip, allegedly causing unnecessary death and suffering to animals under pressure from CEO Elon Musk.

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