Elon Musk’s brain-implant company Neuralink announced on Thursday that it has been granted official approval from the U.S. Food and Drug Administration (FDA) to launch its first-in-human clinical study.
“We are excited to share that we have received the FDA’s approval to launch our first-in-human clinical study!” Neuralink wrote on Twitter.
“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,” it added.
The company said recruitment is not yet open for the clinical trial. However, anyone interested to participate in the clinical trial can register their information on Neuralink’s patient registry.
According to the website, “anyone within the United States who is at least 18 years old and the age of majority in their state, who is able to consent, and who has quadriplegia, paraplegia, vision loss, hearing loss, and/or the inability to speak, is invited to participate in the Patient Registry.”
Adding, “If you participate in the Patient Registry and we determine that you meet preliminary eligibility for future clinical trials, we may contact you to inform you of these trials once they become available.”
The goal of Neuralink is to develop a brain-machine interface technology, often referred to as a neural lace, that establishes a direct connection between the human brain and external computer.
The brain-implant interface developed by Neuralink involves the insertion of tiny, flexible electrode threads into the brain. These threads are thinner than human hair and are designed to minimize damage to brain tissue during the implantation process. The threads contain numerous electrodes that can detect and stimulate neural activity.
One of the primary objectives of Neuralink’s brain-implant interface is to address neurological conditions such as paralysis, spinal cord injuries, and various brain disorders.
We are building surgery simulations for faster iteration and better test coverage. Join us to help expand this capability #techtuesday pic.twitter.com/JHFM5HersL
— Neuralink (@neuralink) March 21, 2023
The company was founded in 2016 and only sought FDA approval in early 2022, in which the agency rejected the application, Reuters reported.
Elon Musk congratulated the Neuralink team for this new development.
Congratulations Neuralink team! https://t.co/AWZGf33UDr
— Elon Musk (@elonmusk) May 26, 2023
Our surgical robot uses advanced imaging systems to detect the brain and insert threads away from blood vessels. Here, you can see everything the robot sees while we test the accuracy of each of the robot’s high-precision cameras #techtuesday pic.twitter.com/c5rklTp2m4
— Neuralink (@neuralink) May 23, 2023
Through the development of Neuralink’s brain-implant interface, Elon Musk envisions a future where humans can merge with artificial intelligence, expanding human cognitive abilities and enabling more seamless interaction with technology.
While the approval is hailed as a significant milestone for Neuralink, critics argue that there are several potential risks and ethical implications associated with the technology.
One of the primary concerns raised is privacy and security concerns. Critics argue brain-implant interfaces involve the transmission and storage of neural data, which raises apprehensions about unauthorized access, data breaches, or even the potential for manipulation.
On one hand, I’m absolutely terrified with the inevitable privacy, safety, and ethical implications of Neuralink.
On the other hand, I want to be able to record my dreams and use MidJourney and Photoshop as plugins to create any image I could literally ever imagine pic.twitter.com/clVlF34kWl
— 【 . 】 (@Vox_Oculi) May 25, 2023