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FDA approves Siemens’ hand-held portable coagulation analyzer

MDBR Staff Writer Published 05 October 2016

Siemens Healthineers has secured 510(k) clearance from the US Food and Drug Administration (FDA) for its hand-held portable coagulation analyzer.

The Xprecia Stride Coagulation Analyzer has been developed to deliver Prothrombin Time International Normalized Ratio (PT/INR) testing for point-of-care monitoring and management of oral anticoagulation therapy with vitamin K antagonist warfarin,

As part of therapy monitoring for patients, many PT/INR tests will be administered for different conditions such as atrial fibrillation, heart valve replacement surgery, deep vein thrombosis and congenital heart defects.

Xprecia Stride analyzer will enable healthcare professionals to carry out PT/INR tests in physician offices and walk-in clinics.

The new analyzer can be controlled at virtually any angle and brought directly to the patient’s finger for effective and comfortable blood sample application.

Xprecia Stride analyzer features an intuitive user interface, as well as an integrated barcode scanner to simplify data capture and improve patient workflow. It also features simple icons and animation in a color display similar to mobile devices.

In addition, the analyzer uses sDade Innovin reagent to minimize any potential for variability.

Siemens Healthineers North America point of care senior vice president Michael Sampson said: “Among the many challenges of point of care testing, accuracy and safety have become paramount to both the user and patient.

“With the Xprecia Stride analyzer, Siemens Healthineers delivers on the promise to bring a safe and lab-accurate test directly to the patient.”

“By adding the Xprecia Stride analyzer to our existing product portfolio in the U.S., we now have the ability to cover the full range of hemostasis testing from the hospital lab to the physician’s office.”