Neuralink, Elon Musk’s brain-technology startup, announced that it has received approval to initiate a feasibility study using its brain implant and a prototype robotic arm.
The PRIME research is being conducted to evaluate the safety of Neuralink’s wireless brain-computer interface and surgical robot. The study focuses on individuals with quadriplegia, a form of paralysis, assessing the implant’s impact on their ability to control external devices using only their thoughts.
In a post on the social platform X, Neuralink confirmed its plans to cross-enroll participants from the existing PRIME study into the ongoing feasibility research.
The U.S. Food and Drug Administration (FDA) and Neuralink have not yet provided additional details about the feasibility study.
Neuralink previously achieved successful device implantation in two patients in the United States. One participant could engage in activities such as playing video games, browsing the internet, posting on social media, and moving a cursor on a laptop. The second participant has been using the device to play online games and learn how to create 3D objects. According to the company, the device has performed well in both cases.
Last week, Health Canada granted approval for Neuralink to begin testing its technology in the Canadian market. A team of Canadian neurosurgeons and the company received authorization to enroll six paralyzed individuals in the research.
In the CAN-PRIME trial, Neuralink will implant its device into participants’ brains to study their neural activity. The implant is designed to allow users to operate computers or smartphones using their brains, eliminating the need for cables or physical actions.
According to the company, the study aims to “evaluate the safety of [its] implant and surgical robot and assess the initial functionality of [its Brain Computer Interface] for enabling people with quadriplegia to control external devices with their thoughts.”
The data gathered from these trials will contribute to developing safer implantation methods and enhancing the technology’s capabilities.
