Comparison of rates of safety issues and reporting of trial outcomes for medical devices approved in the European Union and United States: cohort study

@inproceedings{Hwang2016ComparisonOR,
  title={Comparison of rates of safety issues and reporting of trial outcomes for medical devices approved in the European Union and United States: cohort study},
  author={Thomas J Hwang and Elisaveta Sokolov and Jessica M. Franklin and Aaron S Kesselheim},
  booktitle={BMJ},
  year={2016}
}
OBJECTIVE  To evaluate safety alerts and recalls, publication of key trial outcomes, and subsequent US approval of high profile medical devices introduced in the European Union. DESIGN  Cohort study. SETTING  Novel cardiovascular, orthopedic, and neurologic devices approved in the EU through Conformité Européenne marking between 2005 and 2010. DATA SOURCES  Public and commercial databases searched up to January 2016 for press releases and announcements of approvals; public Food and Drug… CONTINUE READING
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