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Medical Devices / Submissions and Approvals

Siemens Healthineers Wins FDA Clearance for Blood Analysis Assays

Feb. 5, 2018
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The FDA cleared two point-of-care blood analysis tests manufactured by Siemens Healthineers.

The company’s Blood Urea Nitrogen test and its Total Carbon Dioxide test are intended to aid clinicians in diagnosing renal diseases and metabolic imbalances.

The tests can be performed on Siemens’ handheld epoc Blood Analysis System to “expand precision medicine performed at the patient-side to enable faster clinical decision making,” said the division of German conglomerate company Siemens AG.

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