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FDA-cleared POC coagulation analyzer, 11/16

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November 2016—Siemens Healthineers received FDA 510(k) clearance for its Xprecia Stride Coagulation Analyzer, a handheld, portable coagulation analyzer designed to deliver fast, reliable prothrombin time international normalized ratio testing for point-of-care monitoring and management of oral anticoagulation therapy with warfarin.

The analyzer aims to meet the growing demand for fast and reliable PT/INR results in physician offices and walk-in clinics. It weighs 10.5 ounces, can be held at virtually any angle, and can be brought directly to the patient’s finger for efficient and comfortable blood sample application. It has an integrated barcode scanner and a user-friendly interface with simple icons, animation, and a color display.

Xprecia Stride uses fresh capillary whole blood and results are expressed as INR. It uses the same Dade Innovin reagent used by Siemens Healthineers central lab analyzers to minimize any potential for variability. Studies have shown the performance to be equivalent to a reference laboratory hemostasis system, with results available within minutes, the company said in a statement.

Siemens Healthineers, 888-826-9702

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