India-based AI health technology company Qure.ai has received a Class-3 medical device licence from Health Canada, for its AI-powered medical imaging solutions.
The licence approval allows Qure.ai to expand into the Canadian healthcare market, providing AI-powered tools that support hospital clinicians to deliver superior patient care.
Health Canada granting Class 3 classification means that Qure.ai’s AI solutions are thoroughly evaluated, including evaluation of their safety, effectiveness, and quality.
The Class 3 classification indicates the highest risk category for software-as-a-medical device (SaMD) products and the high safety standards of Qure.ai’s AI solutions in medical imaging.
Qure.ai said its AI solutions are designed to support and enhance diagnostic accuracy and effectiveness to improve patient outcomes through earlier detection.
Qure.ai co-founder and CEO Prashant Warier said: “Receiving the Class 3 licence from Health Canada is a testament to the rigour 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 3 licence covers all of Qure.ai’s AI solutions, including qXR for detecting a wide range of abnormalities in chest X-rays, and qXR for lung nodule management on Chest CT.
It includes the company’s qER solution for supporting rapid detection of stroke, traumatic brain injuries, and other neurological conditions in hospital emergency or teleradiology settings.
The licence also includes AI to accurately detect and measure endotracheal and tracheostomy tube tips, identify pneumothorax, and triage critical findings using plain film chest radiography.
It also includes the Qure app for lung cancer and radiology workflows to help clinicians remotely view and diagnose X-rays, CT, MR, and other scans.
Qure.ai said its AI-powered solutions simplify patient care and offer critical alerts while supporting early intervention and improved outcomes in prehospital and emergency settings.
