Neuralink announced that it has got approval from FDA to conduct its "first-in-human clinical study." The company added that the recruitment for the clinical trial is yet to begin and it will drop more information in the coming future.
We are excited to share that we have received the FDA’s approval to launch our first-in-human clinical study!
— Neuralink (@neuralink) May 25, 2023
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…
Based in Fremont, California, Neuralink was founded in 2016 and funded entirely by Elon Musk but the brain implant company made its public appearance in March 2017. Over the years, it has been working on a general-purpose, high-bandwidth brain-computer interface. Neuralink has tested its underdevelopment tech on animals, for instance, it previously added a wireless implant in a monkey, enabling it to control a computer and play video games.
Neuralink"s practices have been criticized by animal welfare organizations. It was reported last year that Neuralink was under federal investigation over potential animal-welfare violations and internal staff complaints that the animal testing was rushed, causing needless suffering and deaths.
Regarding human trials, the FDA previously rejected the approval of Neuralink"s implant over safety concerns, Reuters reported. There were concerns related to the implant"s lithium-ion battery, its wires migrating to other parts of the brain, and whether the device can be removed without damaging brain tissue. However, there were multiple occasions when Elon Musk tweeted about hopes of starting human trials soon after getting regulatory approval.
Neuralink has publicized its implant as a medical device. Touting a variety of applications for its N1 chip last year, Neuralink said its tech has the potential to restore vision in blind people and allow people with spinal cord injuries to walk. The chip can also allow people with quadriplegia to control their mobile devices and computers with their thoughts.