Qure.ai has received a Class III medical device license from Health Canada for all its medical imaging AI products.
The license allows the company to expand its presence into the Canadian healthcare market, according to the vendor. The Class III license covers all of Qure.ai's flagship software, including qXR for chest x-ray images, cER for triaging neurocritical CT images, and qCT for lung nodule management on chest CT images. It also encompasses the company's Qure lung cancer and radiology workflow app, as well as its AI technology for detecting and measuring endotracheal and tracheostomy tube tips, identifying pneumothorax, and triaging critical findings on plain-film chest radiography.
![A normal mammogram confirmed by three-year radiologic follow-up illustrates reader-marked regions of interest (ROIs) during (A) unaided (round 1) and (B) artificial intelligence (AI)–assisted (round 2) reading. Each colored dot represents an ROI for recall by a human reader. Readers could mark more than one ROI per case, represented by multiple dots of the same color. During AI-assisted reading, the AI system displayed three visible prompts: two with suspicion of malignancy scores of 35% (left mediolateral oblique [L MLO] and craniocaudal [L CC]) and one with a suspicion of malignancy score of 10% (right craniocaudal [R CC]), shown as polygonal overlays. Without AI, six of 10 readers (60%) marked a false-positive ROI. With AI assistance, this fell to two of 10 (20%). R MLO = right mediolateral oblique.](https://img.auntminnie.com/mindful/smg/workspaces/default/uploads/2026/07/2026-07-14-radiology-mammogram-ai-auto-bias.H0bYO8QlWs.jpg?auto=format%2Ccompress&dpr=2&fit=crop&h=167&q=70&w=250)
