United States & Canada — Health Canada
19 shared events · Importance 5 · Last updated Aug 11, 2026
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Regulatory
United States: The United States is one of the initial markets where VueJect will be available following FDA clearance, potentially improving access to advanced cardiac imaging technology.
Canada — Health Canada: Canada — Health Canada authorized VueJect under Medical Device License No. 115637, permitting its sale in Canada.
Aug 11, 2026 · 7 articles
Business
United States: The United States' executive order prioritizing psychedelic therapies for accelerated FDA review and expanded patient access has intensified attention on ibogaine, creating a significant market opportunity.
Canada — Health Canada: Canada — Health Canada's regulation of ibogaine under the Food and Drugs Act and its listing on the Prescription Drug List provides a favorable regulatory environment for Optimi Health's operations.
Jun 08, 2026 · 14 articles
Tech
United States: The United States>>> was the location of the U.S.-led study of daraxonrasib and the initial application for drug licensing to the United States — Food and Drug Administration>>>.
Canada — Health Canada: Canada — Health Canada>>> has not yet received an application to license daraxonrasib in Canada>>>. Its role is to regulate and approve new drugs for use in the country, impacting the timeline for Canadian patient access.
May 29, 2026 · 74 articles
Business
United States: The United States is a target market for future clinical research involving Optimi Health's psilocybin product.
Canada — Health Canada: Canada — Health Canada issued the Drug Establishment Licence (DEL) to Optimi Health, authorizing the company's manufacturing, packaging, labeling, testing, storage, and distribution of controlled drug products.
Jun 02, 2026 · 25 articles
Business
United States: The US is part of North America, which held the largest market share in 2025, supported by strong regulatory frameworks and advanced manufacturing.
Canada — Health Canada: Canada — Health Canada provides supportive regulatory frameworks that facilitate product approvals and market growth in Canada.
Jul 28, 2026 · 6 articles
Business
United States: The standardized workflow in Canada for ClearPoint Neuro's system is already in use in the United States, allowing for consistency in clinical trials.
Canada — Health Canada: Canada — Health Canada granted the Medical Device License to ClearPoint Neuro for its Neuro Navigation System, facilitating its use in Canadian neurosurgery centers.
Apr 20, 2026 · 6 articles
Regulatory
United States: The U.S. is a target market where Diagnosis plans to submit CARA to the FDA; a legacy version is already cleared.
Canada — Health Canada: Canada — Health Canada granted a Class II medical device licence to Diagnosis for the CARA System, marking a regulatory approval.
Jul 27, 2026 · 6 articles
Business
United States: The United States is one of the countries where Allogeneic umbilical cord-derived CD34- cells, non-expanded/dorocubicel has been evaluated in clinical trials and where additional regulatory filings are planned.
Canada — Health Canada: Canada — Health Canada is the regulatory body whose approval is required for Medexus Pharmaceuticals to begin commercializing Allogeneic umbilical cord-derived CD34- cells, non-expanded/dorocubicel in Canada.
Jun 10, 2026 · 6 articles
Business
United States: The United States was the first market where WYNZORA was approved, but is not directly affected by this Canadian launch.
Canada — Health Canada: Canada — Health Canada approved WYNZORA in December 2025, a regulatory prerequisite for the launch.
Aug 20, 2026 · 6 articles
Business
United States: The United States is a key market for Kane's products, where commercial activities have commenced following FDA clearance.
Canada — Health Canada: Canada — Health Canada approval for Kane's products enables commercial sales in Canada, contributing to the company's market presence.
Aug 05, 2026 · 7 articles
Business
United States: Fluctuations in the United States contributed to a decrease in MedMira's loans in default.
Canada — Health Canada: Canada — Health Canada is the regulatory body providing initial feedback to MedMira regarding the approval process for its Multiplo Complete Syphilis Antibody Test.
Jun 30, 2026 · 6 articles
Business
United States: United States>>> is a key market for Diagnosis's CARA platform, with the company pursuing FDA clearance.
Canada — Health Canada: Diagnosis is pursuing regulatory clearance with Canada — Health Canada>>> for its CARA platform, a key milestone for market expansion in Canada.
Jun 05, 2026 · 11 articles
Regulatory
United States: The U.S. is the home country of the FDA; no direct impact from this announcement.
Canada — Health Canada: Canada — Health Canada provided scientific advice on the trial design, consistent with its regulatory role; no direct impact on the agency.
Jul 06, 2026 · 6 articles
Regulatory
United States: Spectral Medical obtained exclusive development and commercial rights for PMX in the United States.
Canada — Health Canada: Canada — Health Canada has licensed PMX for therapeutic use, indicating its approval in Canada.
Jun 25, 2026 · 6 articles
Regulatory
Canada — Health Canada: Canada — Health Canada issued a corresponding notice for the recall of Ryobi pressure washers in Canada, ensuring consumer safety in the region.
Aug 28, 2025 · 7 articles
Regulatory
Canada — Health Canada: Canada — Health Canada is the regulatory body in Canada to which Diagnosis plans to submit CARA for approval, impacting its commercialization in Canada.
Apr 08, 2026 · 6 articles
Domestic
Canada — Health Canada: Canada — Health Canada is the government agency responsible for drug approval processes in Canada. Bill C-286 seeks to streamline its Special Access Program for psilocybin and psilocin, which has been criticized for slow and unpredictable approvals.
Jun 16, 2026 · 6 articles
Tech
Canada — Health Canada: Canada — Health Canada approved the urgent application for exosome therapy on compassionate grounds, allowing the world-first treatment to proceed.
Jun 15, 2026 · 6 articles
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