Active Surveillance of Medical-Device Safety

Registry-Based Prospective, Active Surveillance of Medical-Device SafetyResnic FS, Majithia A, Marinac-Dabic D, Robbins S, Ssemaganda H, Hewitt K, Ponirakis A, Loyo-Berrios N, Moussa I, Drozda J, Normand S-L, Matheny ME
A strategy of prospective, active surveillance of a clinical registry rapidly identified potential safety signals among recipients of an implantable vascular-closure device, with initial alerts occurring within the first 12 months of monitoring. (Funded by the Food and Drug Administration and others.)The New England Journal of Medicine, DOI: 10.1056/NEJMoa1516333

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