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PubMed

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.

PMID: 41429289 ·

J, a, c, k, , T, , G, a, r, d, n, e, r, ;, , J, o, n, a, t, h, a, n, , A, , B, u, s, a, m, ;, , E, r, i, c, , D, , S, h, a, h

ZeitschriftChest
Jahr
PMID41429289

Zusammenfassung

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

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