Koios Medical’s Breast Cancer Analysis Software Gets CE Mark

Koios Medical’s Koios DS (decision-support) Breast software has received CE mark certification, clearing the breast cancer diagnosis software for sale in Europe.

The artificial intelligence-based software, which was based on more than 500,000 ultrasound images of malignant and benign breast lesions, is intended to support the early detection of breast cancer and to help physicians avoid biopsies of benign tissue.

The software produces a “likelihood of malignancy” finding that aligns with the American College of Radiology’s BI-RADS rating scale and Europe’s five-point rating system.