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Title
Automated surveillance to detect postprocedure safety signals of approved cardiovascular devices.
Authors
Resnic, Frederic S; Gross, Thomas P; Marinac-Dabic, Danica; Loyo-Berrios, Nilsa; Donnelly, Sharon; Normand, Sharon-Lise T; Matheny, Michael E
Abstract
Ensuring the safety of medical devices challenges current surveillance approaches, which rely heavily on voluntary reporting of adverse events. Automated surveillance of clinical registries may provide early warnings in the postmarket evaluation of medical device safety.