AIM To examine the current landscape of US Food and Drug Administration (FDA)-approved
artificial intelligence (AI) medical imaging devices and identify trends in clinical validation …

Rationale and Objectives To assess key trends, strengths, and gaps in validation studies of
the Food and Drug Administration (FDA)-regulated imaging-based artificial …

Artificial intelligence (AI) has made impressive progress over the past few years, including
many applications in medical imaging. Numerous commercial solutions based on AI …

Purpose Despite tremendous gains from deep learning and the promise of artificial
intelligence (AI) in medicine to improve diagnosis and save costs, there exists a large …

Abstract Background Intended use statements (IUSs) are mandatory to obtain regulatory
clearance for artificial intelligence (AI)-based medical devices in the European Union. In …

Objectives Map the current landscape of commercially available artificial intelligence (AI)
software for radiology and review the availability of their scientific evidence. Methods We …

The American College of Radiology (ACR)—a professional association representing nearly
40,000 diagnostic radiologists, interventional radiologists, nuclear medicine physicians …

Purpose To provide an overview of important factors to consider when purchasing radiology
artificial intelligence (AI) software and current software offerings by type, subspecialty, and …

There has been an exponential increase in the number of publications and work pertaining
to applications of artificial intelligence (AI) and machine learning (ML) in medicine and in …

Advances in machine learning in medical imaging are occurring at a rapid pace in research
laboratories both at academic institutions and in industry. Important artificial intelligence (AI) …