Global healthcare AI provider Qure.ai has obtained Health Canada’s Class III medical device licence for its suite of medical imaging AI solutions.

This authorisation allows the company to introduce its AI-powered tools to the Canadian healthcare market, aimed at supporting clinicians in delivering enhanced patient care.

Health Canada's Class III classification is indicative of a thorough evaluation process, affirming the safety, effectiveness and quality of Qure.ai's AI solutions.

As the highest risk category for software-as-a-medical device (SaMD) products, this classification highlights the sophisticated capabilities and stringent safety protocols of Qure.ai's algorithms in the field of medical imaging.

The solutions provided by Qure.ai are engineered to support diagnostic precision and efficiency, contributing to improved patient outcomes through the early detection of medical conditions.

The Class III licence encompasses all of Qure.ai's principal offerings, including qXR, an AI tool for chest X-ray analysis that can detect a range of abnormalities and prioritise cases for review.

Other solutions include qCT, which aids in lung nodule management on chest CT scans for lung cancer screening and monitoring; and qER to assist in the quick identification of strokes, traumatic brain injuries, and other neurological issues.

Additionally, Qure.ai's solutions facilitate the accurate detection and measurement of endotracheal and tracheostomy tube placements, identification of pneumothorax, and triaging of critical findings with precision using plain film chest radiography.

The Qure app enhances lung cancer and radiology workflows, enabling clinicians to remotely view and diagnose scans from X-rays, CT, MR, and more.

These AI-powered tools are designed to streamline patient care, provide critical alerts, and support early intervention, improving outcomes in both prehospital and emergency settings.

Qure.ai co-founder and CEO Prashant Warier said: “Receiving the Class III licence from Health Canada is a 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.”

In 2022, the US Food and Drug Administration (FDA) granted 510(k) clearance to Qure.ai’s AI algorithm, qXR-BT.