Netherlands-based artificial intelligence (AI) firm Aidence has been granted the CE Mark for Veye Chest, the company's lung nodule management assistant software.
The approval was one of the first under the European Union's new Medical Device Regulation (MDR) process, according to Aidence. Established in 2017, the new MDR requires medical devices labeled as class IIA or higher to reapply for the CE Mark.
The Veye Chest AI software automatically detects, classifies, and tracks the growth of nodules on chest CT scans. Regulatory clearance for the program required strong risk management, clinical data, and postmarket clinical follow-up, according to Aidence.
The new certification classifies Veye Chest as a class IIB medical device, instead of the previous IIA classification. The software is currently deployed at multiple sites in Europe for routine clinical practice and screening.
![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.auntminnieeurope.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)
