Is there enough scrutiny of artificial intelligence (AI) software prior to clearance by the Food and Drug Administration (FDA) for adjunctive use in breast cancer screening? Despite the FDA clearance in recent years of several AI products to help identify suspicious breast lesions and facilitate mammography triage, researchers suggested in a recent review, published in JAMA Internal Medicine, that questions remain about data sources, clinical outcome measures and external validation. Here are a few takeaways from their review of the research leading to FDA clearance for nine AI-related products for breast cancer screening between January 1, 2017 and December 31, 2021. All of the clearances for the AI products were based on retrospective analysis of previously existing databases. Only six of the nine products had multicenter studies to support their use and research for four of the AI products lacked information about external validation, according to the review.