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Qure.ai Secures Class III Medical Device Licence from Health Canada

NextEdge Admin

22 Jul 2024

2 min 36 sec

Qure.ai, a leader in healthcare AI, has achieved a major milestone with the receipt of a Class III medical device licence from Health Canada for its entire range of medical imaging AI solutions. This prestigious certification allows Qure.ai to extend its impact into the Canadian healthcare sector, providing advanced AI tools designed to support clinicians in delivering superior patient care.

Health Canada's Class III designation signifies that Qure.ai's AI solutions have undergone rigorous evaluation for safety, effectiveness, and quality. This classification, the highest risk category for Software-as-a-Medical Device (SaMD) products, highlights the advanced capabilities and robust safety standards of Qure.ai's algorithms in medical imaging.

Qure.ai's suite of AI solutions includes:

- qXR: An AI tool for chest X-rays that detects and localizes lung nodules, optimizes lung cancer pathways, and prioritizes cases for faster clinical review.
- qCT: AI for managing lung nodules on Chest CT, aiding in screening programs and monitoring lung cancer progression.
- qER: AI for neurocritical CT, rapidly detecting strokes, traumatic brain injuries, and other neurological conditions in emergency and teleradiology settings.
- Qure app: A platform that enables remote viewing and diagnosis of X-rays, CT, MR, and other scans, enhancing radiology workflows.

Prashant Warier, Co-founder & CEO of Qure.ai, emphasized that the Class III licence reflects the quality and rigor of their AI algorithms, allowing them to support Canadian healthcare professionals with accurate and efficient diagnostic tools. This approval builds on Qure.ai’s existing global footprint, including FDA clearances and EU MDR CE mark approvals, reinforcing their commitment to enhancing healthcare standards worldwide through advanced AI solutions.