The number of AI/ML-enabled medical devices with Conformité Européenne (CE) mark approval is greater; from a comprehensive review of devices approved between August 2014 and August 2020,34 we identified eight additional AP devices (predominantly in the areas of breast and prostate cancer diagnosis, lymph node metastasis detection, breast immunohistochemistry interpretation, and Ki67 hotspot scoring). This evidence concerns the gene MKI67 and metastatic malignant neoplasm in the lymph nodes.