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Neuralink Expands Human Trials to Canada Following Health Canada Approval

8 months ago2 min read

Key Insights

  • Neuralink has received approval from Health Canada to begin human trials of its brain-computer interface (BCI) implant, marking its first clinical trials outside the U.S.

  • The trials, named CAN-PRIME study, will evaluate the safety of Neuralink's implant and surgical robot, as well as the initial functionality of the BCI for enabling individuals with quadriplegia to control external devices with their thoughts.

  • Neuralink is actively recruiting participants in Canada who have limited or no use of their hands due to cervical spinal cord injury or amyotrophic lateral sclerosis (ALS).

Neuralink has secured approval from Health Canada to initiate human trials of its brain-computer interface (BCI) technology, expanding its clinical research beyond the United States. The CAN-PRIME study will be conducted at Toronto Western Hospital, which will serve as the exclusive surgical site. This marks a significant step for Neuralink as it seeks to evaluate the safety and efficacy of its implant in enabling individuals with quadriplegia to control external devices using their thoughts.
The CAN-PRIME study aims to assess the safety of Neuralink's implant and surgical robot, while also evaluating the initial functionality of its BCI. The technology is designed to interpret neural activity, allowing participants to control computers and smartphones without physical movement. Neuralink is specifically seeking individuals with limited or no ability to use both hands due to cervical spinal cord injury or amyotrophic lateral sclerosis (ALS).
Neuralink's first human patient in the U.S. received an implant earlier this year. While the patient experienced some initial issues with thread retraction, Neuralink implemented mitigation measures for its second patient to prevent similar problems. The second patient was reportedly using computer-aided design (CAD) software within weeks of the surgery, demonstrating the potential of the technology.
"Recruitment is now open," Neuralink announced on X, inviting potential participants to join the CAN-PRIME study. The company hopes that the trials will provide valuable insights into improving the safety and capabilities of its BCI technology. The data collected will be used to refine surgical techniques and enhance the functionality of the implant, ultimately aiming to improve the quality of life for individuals with paralysis.
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