Singapore-based medtech firm Us2.ai has received the CE Mark for Us2.v1, an automated decision support tool for echocardiography.
The company received U.S. Food and Drug Administration clearance in 2021 and Health Sciences Authority Singapore clearance in 2022. Us2.v1 is now available for clinical use in the U.K. and across Europe, the U.S., Canada, Australia, New Zealand, and Singapore.
Us2.v1 is an automated clinical workflow application with the ability to recognize and analyze 2D and Doppler echo images for comprehensive measurements needed for diagnosis, prediction, and prognosis of heart disease and pulmonary hypertension.
![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)
