Neuralink has also come under fire from activist groups for its alleged treatment of animals. 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. 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.
The FDA's approval for an in-human study is a significant win for Neuralink after a series of recent hurdles at the company.
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Patients will then be able to control external mice and keyboards through a Bluetooth connection, according to the company's website. Patients with Neuralink devices will learn to control it using the Neuralink app. The Link is connected to a series of thin, flexible threads inserted directly into the brain tissue where they detect neural signals. Its system centers around the Link, a small circular implant that processes and translates neural signals. Neuralink's BCI will require patients to undergo invasive brain surgery. But by receiving the go-ahead for a study with human patients, Neuralink is one step closer to market. No BCI company has managed to clinch the FDA's final seal of approval. But receiving FDA approval for a commercial medical device is no small task - it requires companies to successfully conduct several extremely thorough rounds of testing and data safety collection. Scientists have been studying BCI technology for decades, and several companies have developed promising systems that they hope to bring to market. 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. A BCI is a system that deciphers brain signals and translates them into commands for external technologies. Neuralink is part of the emerging brain-computer interface, or BCI, industry.
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Neuralink said in a tweet that patient recruitment for its clinical trial is not open yet. The extent of the approved trial is not known. The FDA and Neuralink did not immediately respond to CNBC's request for comment. "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. Personal Loans for 670 Credit Score or Lower Personal Loans for 580 Credit Score or Lower Best Debt Consolidation Loans for Bad Credit
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