Elon Musk’s brain implant company, Neuralink, announced Thursday that it has received official approval from the US Food and Drug Administration (FDA) to launch its first-in-human clinical study.
“We are excited to share that we have received FDA approval to launch our first 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,” he added.
The company said that recruitment is not yet open for the clinical trial. However, any person interested in participating in the clinical trial can register their data in the Neuralink patient registry.
According to the website, “anyone within the United States who is at least 18 years of age 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, you are invited to participate in the Patient Registry”.
Adding: “If you participate in the Patient Registry and we determine that you meet the preliminary requirements for future clinical trials, we may contact you about these trials once they become available.”
Neuralink’s goal is to develop a brain-machine interface technology, often called a neural cord, that establishes a direct connection between the human brain and the external computer.
The brain-implant interface developed by Neuralink involves inserting small, flexible electrode wires 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 main goals of the Neuralink brain-implant interface is to address neurological conditions such as paralysis, spinal cord injuries, and various brain disorders.
LOOK:
We are building surgery simulations for faster iteration and better test coverage. Join us in helping expand this capacity. #technologicalTuesday pic.twitter.com/JHFM5HersL
—Neuralink (@neuralink) March 21, 2023
The company was founded in 2016 and only sought FDA approval in early 2022, when the agency rejected the application, Reuters reported.
Elon Musk congratulated the Neuralink team on 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 the blood vessels. Here you can see everything the robot sees as we test the accuracy of each of the robot’s high-precision cameras. #technologicalTuesday pic.twitter.com/c5rklTp2m4
—Neuralink (@neuralink) May 23, 2023
Through the development of the Neuralink brain-implant interface, Elon Musk envisions a future where humans can merge with artificial intelligence, expand human cognitive abilities, and enable more seamless interaction with technology.
While the approval is hailed as a major milestone for Neuralink, critics argue that there are several potential risks and ethical implications associated with the technology.
One of the main concerns raised is privacy and security. Critics argue that brain-implant interfaces involve the transmission and storage of neural data, raising fears of unauthorized access, data leaks, or even the possibility of tampering.
On the one hand, I am absolutely terrified of the inevitable ethical, privacy and security 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 can literally imagine. pic.twitter.com/clVlF34kWl
— 【 . 】 (@Vox_Oculi) May 25, 2023
