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    FDA's Workshop on Troponin Assays Approval Fosters Agreement, Debate

    This article discusses a recent FDA workshop held for troponin assays, tests designed most commonly to detect the release of cardiac troponin following Acute Myocardial Infarction (AMI). The authors review the history, uses and issues associated with using troponin - a three protein complex, released rapidly into the blood after myocardial injury - and innovative medical devices to detect troponin levels, as an assay to aid in the diagnosis of an AMI event. Regulatory pro...