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). The gene discussed is MKI67; the disease is Familial prostate cancer.