Artificial Intelligence in Breast Cancer Screening: Evaluation of FDA Device Regulation and Future Recommendations.

Abstract

Contemporary approaches to artificial intelligence (AI) based on deep learning have generated interest in the application of AI to breast cancer screening (BCS). The US Food and Drug Administration (FDA) has approved several next-generation AI products indicated for BCS in recent years; however, questions regarding their accuracy, appropriate use, and clinical utility remain. To describe the current FDA regulatory process for AI products, summarize the evidence used to support FDA clearance and