Fig. 1: Overview of types of FDA-cleared CAD products and their integration into medical image interpretation workflows.

CAD types vary according to their outputs and place within the clinical workflow. CADt (triage) devices are designed to flag cases for prioritized review and do not place marks on the image. CADe (detection) devices mark regions of interest to aid in the detection of lesions as a clinician is interpreting an exam. CADx (diagnosis) devices are designed to aid in diagnosis, such as by outputting a score or category, but do not explicitly detect lesions across the exam. CADe/x (detection & diagnosis) devices provide both detection and diagnosis support. Finally, an autonomous system, which we denote as CADa, aims to automatically interpret the exam without clinician input.