Breast cancer AI cleared for EU markets
The European Union has granted CE mark approval to a U.S.-based maker of AI software that aids radiologists in distinguishing between benign and malignant lesions on breast ultrasound images.
The software, which has been on the market here since 2018, is Koios DS Breast Smart Ultrasound, a decision-support tool developed by Koios Medical of New York City and Chicago.
The company says it trained the model on more than half a million images and has aligned it with both the American College of Radiology’s BI-RADS rating schema and the European five-point rating systems.
Koios VP Lev Barinov, PhD, says use of the software can “consistently elevate the performance of any trained physician interpreting breast ultrasound to the level of accuracy of a world class breast expert.”
Dave P. has worked in journalism, marketing and public relations for more than 30 years, frequently concentrating on hospitals, healthcare technology and Catholic communications. He has also specialized in fundraising communications, ghostwriting for CEOs of local, national and global charities, nonprofits and foundations.