Digital pathology imaging artificial intelligence in cancer research and clinical trials: An NCI workshop report.

Abstract

Digital pathology imaging (DPI) is a rapidly advancing field with increasing relevance to cancer diagnosis, research, and clinical trials through large-scale image analysis and artificial intelligence (AI) integration. Despite these advances, regulatory adoption in digital pathology (DP) has lagged; to date, only three AI/ML Software as a Medical Device tool have received FDA clearance, highlighting a validation dataset gap rather than an absence of regulatory pathways. On March 6-7, 2024, the N