Siemens’ TnIH assays land FDA clearance

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September 2018—Siemens Healthineers announced FDA clearance of its High-Sensitivity Troponin I assays (TnIH) for its Atellica IM and Advia Centaur XP/XPT in vitro diagnostic analyzers to aid in the early diagnosis of myocardial infarctions. The high-sensitivity performance of the TnIH assays “offers the ability to detect lower levels of troponin at significantly improved precision at the 99th percentile and detect smaller changes in a patient’s troponin level as repeat testing occurs,” the company said in a statement.