Clinical Evidence to Support US Food and Drug Administration Review of New Medical Technology in Pulmonary, Sleep, and Critical Care Medicine Between 2014 and 2024: A Scoping Review to Support Adoption in Practice.

Abstract

Chest medicine relies extensively on medical devices that comprise medical technology, artificial intelligence, software applications, and digital health; however, a comprehensive assessment of the evidence supporting US Food and Drug Administration (FDA) approval/clearance of these devices is lacking. What are the trends and evidence related to new medical devices across chest medicine? We performed a scoping review according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses