Trends in clinical validation and usage of US Food and Drug Administration-cleared artificial intelligence algorithms for medical imaging.

Abstract

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 strategy. A retrospective study was conducted that analysed data extracted from the American College of Radiology (ACR) Data Science Institute AI Central database as of November 2021 to identify trends in FDA clearance of AI products related to medical imaging. Product and clinical validation information of each device