How the FDA Regulates AI.

Abstract

Recent years have seen digital technologies increasingly leveraged to multiply conventional imaging modalities' diagnostic power. Artificial intelligence (AI) is most prominent among these in the radiology space, touted as the "stethoscope of the 21st century" for its potential to revolutionize diagnostic precision, provider workflow, and healthcare expenditure. Partially owing to AI's unique characteristics, and partially due to its novelty, existing regulatory paradigms are not well suited to