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Warfarin Monitoring Device From CoaguSense Cleared by FDA

NEW YORK (360Dx) – Anticoagulation monitoring technology firm CoaguSense said this week that the US Food and Drug Administration has cleared the company's second-generation prothrombin time/international normalized ratio monitoring system for patients on warfarin (Coumadin).

The Coag-Sense PT2 meter was 510(k)-cleared by the FDA for professional use in a CLIA-waived setting and for self-testing by patients at home. The system, which can be carried around in a lab coat pocket, has built-in Wi-Fi and Bluetooth and offers USB and wired ethernet connectivity options, Fremont, California-based CoaguSense said, adding the device can store up to 2,000 test results and 500 quality control results.

"The Coag-Sense PT2 meter is the result of the continuous innovation of a test system based on the same mechanical principle as the World Health Organization's gold standard tilt-tube method and the research grade fibrometer," CoaguSense President and CEO Douglas Patterson said in a statement.