Elon Musk’s brain-implant company Neuralink says it has received a green light from the US Food and Drug Administration (FDA) to launch its first human clinical study.
On Thursday Neuralink wrote on Twitter: “We are excited to share that we have received the FDA’s approval to launch our first-in-human clinical study!”
It added: “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”
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TGP reports: 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.
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.