Ibex Medical Analytics announced today that it received CE mark approval for its Galen AI-based breast cancer diagnostic platform.
Tel Aviv, Israel–based Ibex’s Galen platform uses AI and machine learning technology based on hundreds of thousands of image samples scanned from biopsy slides through digital pathology, according to a news release.
Galen previously won CE mark approval as a software platform for identifying suspected cancer on prostate core needle biopsies. Multiple pathology labs around the world have already deployed it in routine clinical practice to help improve diagnostic accuracy, Ibex said.
European approval follows results from a blinded, multi-site clinical study at Institut Curie in France and Maccabi Healthcare Services in Israel, with the platform demonstrating high accuracy in detecting various types of breast cancer, including invasive and in-situ cancers. It also distinguished between different types of cancer and grading of DCIS lesions.
“We are proud to have obtained this milestone CE Mark for our Galen Breast solution” Ibex CSO Daphna Laifenfeld said in the release. “The excellent results coming out of this study demonstrate the robustness of our strong AI technology and enable us to offer pathologists an unprecedented breadth of features. We have secured multiple orders for Galen Breast from leading health systems in Europe, and we look forward to accelerating its deployment in the very near future.”
