PubMed

Radiological Medical Device Innovation: Approvals via the Premarket Approval Pathway From 2000 to 2015.

PMID: 28061962 · 2017

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学術誌Journal of the American College of Radiology : JACR

年2017

PMID28061962

抄録

The aim of this study was to critically assess the clinical evidence leading to radiologic medical device approvals via the premarket approval pathway from 2000 to 2015. This study used the publically available FDA premarket database for radiologic device approvals over the past 15 years (September 1, 2000, to August 31, 2015). Approval characteristics were collected for each device, and statistical analysis was performed on the data for each pivotal trial. Additionally, methodological quality o

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