Healthcare artificial intelligence (AI) systems provider, Qure.ai, has announced its receipt of a Class III medical device license from Health Canada for all its medical imaging AI solutions according to a statement released by the company, led by co-founder and CEO, Prashant Warier. Image courtesy: Qure.ai
July 22, 2024 — Healthcare artificial intelligence (AI) systems provider, Qure.ai, has announced its receipt of a Class III medical device license from Health Canada for all its medical imaging AI solutions. This significant milestone enables Qure.ai to expand its presence into the Canadian healthcare market, providing AI-powered tools that support hospital clinicians to deliver superior patient care.
Health Canada's Class III classification reflects a comprehensive evaluation of Qure.ai's AI solutions, including rigorous assessments of safety, effectiveness, and quality, according to a written statement released by the company. This classification, indicating the highest risk category for Software-as-a Medical Device (SaMD) products, underscores the advanced capabilities and robust safety standards of Qure.ai's AI-powered algorithms in medical imaging.
The company further added that Qure.ai’s solutions are designed to assist and enhance diagnostic accuracy and efficiency, focused on improving patient outcomes through earlier detection. The Class III license covers all Qure.ai's flagship solutions, including the following applications:
- AI to optimize lung cancer pathways via qXR, an AI tool for detecting a wide range of abnormalities in chest X-rays, including detecting and localizing lung nodules plus automatically prioritizing normal vs abnormal cases for swift clinical review and reporting; and qCT, AI for lung nodule management on Chest CT to empower screening programs and track volumetric growth as part of lung cancer progression monitoring;
- AI to triage neurocritical CT via qER aiding in the rapid detection of stroke, traumatic brain injuries, and other neurological conditions in hospital emergency or teleradiology settings;
- AI to accurately detect and measure endotracheal and tracheostomy tube tips, identify pneumothorax, and triage critical findings with precision using plain film chest radiography;
- Qure app for lung cancer and radiology workflows to enable clinicians to remotely view and diagnose X-rays, CT, MR, and other scans. The AI-powered solutions, including qXR, qER, and qCT streamline patient care and provide critical alerts while supporting early intervention and improved outcomes in prehospital and emergency settings.
"Receiving the Class III license from Health Canada is testament to the rigor and quality of our AI algorithms,” said Qure.ai Co-founder and CEO, Prashant Warier. He continued, “This approval allows us to bring our already globally proven AI solutions to the Canadian healthcare market, where we can support healthcare professionals in making earlier, more accurate and efficient diagnoses.”
The Class III medical device license approval from Health Canada adds to a growing roster of US Food and Drug Administration's (FDA) AI clearances and European Union Medical Device Regulation (EU MDR) CE mark approvals delivering trust in AI safety and providing global healthcare access to proven AI tools.
More information: www.qure.ai
Related content:
AI-POWERED LUNG CANCER CARE CONTINUUM UNVEILED AT ASCO 2024
QURE.AI ADDS NEW FDA BREAKTHROUGH DEVICE STATUS TO GROWING LIST OF REGULATORY MILESTONES
February 03, 2026 
