Artificial intelligence (AI) software developer Qure.ai has secured CE Class IIb certification for medical devices under the auspices of the European Union Medical Device Regulation (EU-MDR).
The company's software covered by the certification helps clinicians detect abnormalities from data gathered from multiple imaging modalities, including chest and musculoskeletal x-ray, chest CT, and head CT, Qure.ai said.
In other Qure.ai news, at the upcoming ECR in Vienna, the firm plans to present in collaboration with CaritasKlinikum Saarbrücken in Germany an "AI playbook" that will offer European clinicians and radiologists a guide for understanding the use of AI in radiology.
![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)
