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Tag Archives: Siemens Healthineers—

Twelve assays get PMA for Siemens’ Atellica

Dec. 18, 2018—Siemens Healthineers has been granted 12 premarket approvals from the FDA for its infectious disease and oncology testing menu. “These 12 PMA assays, combined with recently released High-Sensitivity Troponin I and Procalcitonin assays, provide a comprehensive menu on the Atellica Solution. Laboratories seeking a broad menu supporting the needs of their clinicians and patients can now find it ...

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Siemens ELF test designated as a breakthrough device

Nov. 14, 2018—The FDA has granted a breakthrough device designation for the Advia Centaur Enhanced Liver Fibrosis Test from Siemens Healthineers. The ELF Test would support clinicians, in conjunction with additional clinical evidence, in assessing the fibrosis stage of chronic liver disease through a blood test. The test is designed to analyze data regarding three serum biomarkers—hyaluronic acid, procollagen III ...

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FDA clears Siemens’ TnIH assays

July 30, 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 of the TnIH assays “offers the ability to detect lower levels of troponin at significantly improved precision at the 99th percentile and ...

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Siemens lands FDA clearance for BUN, TC02 tests

Feb. 1, 2018—Siemens Healthineers announced today it received 510(k) clearance from the FDA for its blood urea nitrogen (BUN) and total carbon dioxide (TCO2) point-of-care tests to aid in the diagnosis of renal diseases and metabolic imbalances. Siemens can now provide a full menu on a single test card within the blood analysis market for clinicians to perform at the ...

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Siemens acquires Fast Track Diagnostics

Dec. 19, 2017—Siemens Healthineers has signed an agreement to acquire Luxembourg-based Fast Track Diagnostics, a supplier of diagnostics tests that can distinguish between viral, bacterial, or other infections in one test. By introducing FTD products to its molecular diagnostics portfolio, Siemens is further investing in precision medicine and better patient experience through solutions that eliminate the need for repeat diagnostic ...

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