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Tag Archives: Siemens Healthineers—

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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FDA-cleared Atellica Solution, 9/17

September 2017—Siemens Healthineers showcased its Atellica Solution, flexible, scalable, automation-ready immunoassay and chemistry analyzers for laboratory diagnostics, at the 69th AACC Annual Scientific Meeting and Clinical Lab Expo. The 510(k)-cleared Atellica Solution, for mid- and high-volume labs, comprises sample management and immunoassay and chemistry analyzer components.

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Siemens buys Epocal from Alere, 8/17

August 2017—Siemens Healthineers has entered into a definitive agreement to acquire Epocal, a subsidiary of Alere. Epocal develops and provides point-of-care blood diagnostic systems for health care enterprises, including the epoc Blood Analysis System, a handheld, wireless testing solution.

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Siemens buys Epocal from Alere

July 26, 2017—Siemens Healthineers has entered into a definitive agreement to acquire Epocal, a subsidiary of Alere. Epocal develops and provides point-of-care blood diagnostic systems for health care enterprises, including the Epoc Blood Analysis System, a handheld, wireless testing solution. The transaction is subject to the completion of Abbott’s acquisition of Alere, as well as antitrust approvals and other customary ...

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