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Health Canada approval for Neuralink’s CAN-PRIME human trial in Canada was announced in November 2024—not newly. Neuralink said recruitment was open, and UHN Foundation named Toronto Western Hospital as the Canadian surgical site. Those announcements do not establish whether the trial is recruiting today or whether a Canadian participant has since received an implant.
What is the current status of Neuralink’s Canadian trial?
The latest confirmed announcements in the available record are from November 2024. Neuralink announced on November 20 that Health Canada had approved CAN-PRIME and that the study was open for recruitment. On November 22, UHN Foundation said Toronto Western Hospital had been selected as the Canadian site and that recruitment had Health Canada approval. Neither announcement confirms the trial’s status as of October 4, 2026.
UHN’s announcement described an implantation procedure that “will involve” the participant; it was a site and recruitment announcement, not evidence that a Canadian implantation had occurred. The Health Canada portal information available here does not establish a CAN-PRIME record or current status. For a current answer, check Neuralink’s trial record or contact the sponsor; treat an older announcement as historical rather than proof that enrollment remains open.
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CAN-PRIME stands for Canadian Precise Robotically Implanted Brain-Computer Interface. Neuralink describes it as an investigational medical-device study of its fully implantable, wireless brain-computer interface. The stated aims are to assess the safety of the N1 implant and R1 surgical robot, and to evaluate initial function of the interface—including whether participants with quadriplegia can use their thoughts to control external devices.
These are research aims, not demonstrated treatment benefits or proof of long-term safety. The official and institutional announcements cited here provide no CAN-PRIME participant count or numerical outcome or efficacy result.
Where is the Canadian study taking place?
UHN Foundation identified Toronto Western Hospital as the Canadian surgical site in its November 22, 2024 announcement, describing it as the first and exclusive Canadian site at that time. This establishes the site named in that announcement, not its present recruitment status.
UHN President and CEO Dr. Kevin Smith said: “As the first and exclusive surgical site in Canada to perform this procedure, we will be continuing to shape the future of neurological care and further defining our track record for doing what hasn’t been done.” This was an institutional statement about UHN’s role, not evidence that the device is effective.
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Who may be eligible to join?
Neuralink’s November 2024 announcement said Canadian residents with limited or no ability to use both hands because of amyotrophic lateral sclerosis (ALS) or cervical spinal cord injury could be eligible. UHN also identified these as potential eligibility groups. These summaries are not the full inclusion and exclusion criteria, and they do not establish that applications are currently being accepted.
Use the sponsor’s current trial record for the complete criteria, location details, and enrollment status. Do not assume that someone qualifies based only on a diagnosis or the brief eligibility description in the announcements.
Does Health Canada approval mean Neuralink is approved for sale in Canada?
No. The 2024 approval described by Neuralink and UHN was approval to conduct a clinical trial, not authorization to sell the device or offer it as routine clinical treatment. Health Canada distinguishes its review, approval, and monitoring of Canadian clinical trials from the separate process companies follow to obtain authorization for a health product to be sold.
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Look for CAN-PRIME in Neuralink’s current trial information and confirm that the record is current. Use the sponsor’s record for its stated eligibility criteria and contact details.
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Search Health Canada’s Canadian Clinical Trial Search Portal and follow any linked registry record. The portal is a search tool with selected trial information and registry links, not a comprehensive registry.
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Check the record’s status date and source. Health Canada says portal status information comes from sponsor-provided records in international registries and may be stale; it advises contacting the sponsor when details need confirmation. In the portal, “Recruiting” means participants are currently being recruited, while “Not yet recruiting” means no participants have yet been recruited or enrolled at any site.
Health Canada’s clinical-trial registration and results guidance took effect July 29, 2026. For trials within its scope, the guidance says sponsors are expected to register ideally before enrollment opens in Canada and no later than 21 calendar days after the first participant is enrolled. It also says sponsors are expected to submit summary results within 12 months after primary study completion. Health Canada describes these as policy expectations, not legal requirements.
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