Neuralink confirmed that it received approval from the United States Food and Drug Administration for its brain device clinical study on humans. And while it can be considered a huge step forward for the medical and tech industry, the news received varying reactions from the public, with most people expressing doubts.
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…
— Neuralink (@neuralink) May 25, 2023
Neuralink’s project is not new. Another company called Synchron also tried implanting its Stentrode chip in a human brain in July 2021 and shared its findings, saying the participants “were able to use the implant to generate digital switches under intentional control for routine digital activities, such as texting, emailing, personal finance, online shopping, and communication of care needs.” Nueralink has the same ambition but attracted more attention, thanks to Elon Musk‘s support and investment.
Now, after countless tweets from Musk promising the nearing human trial of the implant, Neuralink shared that it finally received approval from the FDA. To recall, the agency first rejected the company’s request in 2022. Reuters reported “dozens of issues the company must address before human testing,” adding the FDA questioned whether removing the implant could damage the brain tissue.
💪🏽👀🦾 pic.twitter.com/jJ1Glzi6rp
— Neuralink (@neuralink) April 16, 2021
Neuralink didn’t share exactly how it resolved these concerns, but many still doubt the ambitious project, especially now that it will be performed on humans. Many recollected the past results of Neuralink’s operations and tests on animals, which were lambasted by animal welfare advocates due to reported deaths caused by rushed testing.
Despite this, Neuralink managed to obtain the nod of the FDA. Yet, it is worth noting that recruitment for clinical trial participants is not yet open, the company stressed, adding it would “announce more information on this soon.” This raises the question of who would be willing to join the trial, causing some to revisit Musk’s past claim he would have the implant in the future and challenging Nueralink to “do Elon first.”
