New York, July 22 2024: Qure.ai, a global leader in healthcare AI, has received a Class III medical device licence 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.
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Health Canada's Class III classification reflects a comprehensive evaluation of Qure.ai's AI solutions, including rigorous assessments of safety, effectiveness, and quality. 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.
Qure.ai’s solutions are designed to assist and enhance diagnostic accuracy and efficiency, ultimately improving patient outcomes through earlier detection. The Class III licence covers all Qure.ai's flagship solutions. This includes:
- AI to optimise 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 prioritising 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.
Prashant Warier, Co-founder & CEO, Qure.ai, states, "Receiving the Class III licence from Health Canada is testament to the rigor and quality of our AI algorithms. 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. This puts patient care at the heart of digital healthcare transformation.”
The Class III medical device licence approval from Health Canada builds on Qure's commitment to refining healthcare standards all around the world. It adds to a growing roster of USA 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.
