Koios Medical has received the CE Mark for its Koios DS Breast Smart Ultrasound decision-support software for interpreting breast ultrasound images.
The software has been in use in the U.S. since 2018. Physicians report it increases cancer detection rates while reducing rates of false positives and benign biopsies, according to the company.
The software was trained on over 500,000 ultrasound images of both malignant and benign breast lesions and is intended to improve physician diagnostic accuracy. The system generates a likelihood of malignancy finding aligned to both the American College of Radiology's BI-RADS rating scale and the European five-point rating system.
![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)
