CE mark for AI-powered breast cancer detection
Medical Analytics, a pioneer in artificial intelligence (AI)-powered cancer diagnostics, has gained CE-marking for the Galen Breast solution for use in supporting pathologists in detection of various types of breast cancer.
The solution is now generally available as Ibex partners with laboratories, hospitals and health systems to implement AI technology into the diagnostic workflow. Galen Breast has already been ordered by multiple laboratories, including a network-wide deployment at a leading pathology group in Europe.
The CE mark follows pioneering results from a blinded, multi-site clinical study at Institut Curie in France and Maccabi Healthcare Services in Israel. Galen Breast demonstrated very high accuracy in detecting various types of breast cancer, including invasive and in situ cancers, distinguishing between different types of invasive cancer (eg, lobular versus ductal carcinoma) and grading of DCIS lesions. These results validate the robustness of Galen Breast and support its adoption by pathology institutes that aim to improve their diagnostic accuracy by enhancing quality control with AI.