By Simon Alvarez

Posted on May 25, 2023

Elon Musk’s brain-computer interface startup, Neuralink, recently announced that it had received approval from the Food and Drug Administration (FDA) to conduct its first in-human clinical study. The company highlighted the milestone in a post on its official Twitter account. 

As noted by Neuralink, the FDA permission is the culmination of the work that the company’s employees have done over the past years. The startup also noted that the first in-human clinical study is a pivotal step towards Neuralink’s goal of helping numerous people. Neuralink, however, also clarified that recruitment for the clinical trials is not open yet.

“We are excited to share that we have received the FDA’s approval to launch our first-in-human clinical study! 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. Recruitment is not yet open for our clinical trial. We’ll announce more information on this soon!” Neuralink noted on its Twitter post.

Shivon Zilis, Neuralink’s Director of Operations and Special Projects, noted on Twitter that the FDA approval for the company’s first human studies is the result of about six years of hard work. The executive also called on people who are interested in the field to come work for the startup, especially as the next steps would be both challenging and worthwhile. 

Neuralink’s primary product is a brain implant called the Link, which is expected to help people with severe paralysis control tech devices through their brains. With such a system in place, even patients with diseases such as ALS could potentially communicate with their loved ones through tech devices. So far, Neuralink has demonstrated the technology working on animals such as monkeys in events like last year’s Show and Tell. 

So far, the extent of Neuralink’s in-human clinical trials remains to be seen, and the FDA has not issued a comment about the matter. That being said, Neuralink’s permission for in-human trials is quite impressive, considering that no brain-computer interface company has been able to secure the FDA’s final seal of approval, as noted in a CNBC report. 

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Neuralink secures FDA approval for first human brain-computer interface trial

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