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.
