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Medical Devices / Submissions and Approvals

FDA Clears Monitor for Coumadin Patients

April 3, 2019
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The FDA granted 510(k) clearance for CoaguSense’s Coag-Sense PT2 meter, a second-generation monitoring device designed for patients taking the blood thinner Coumadin (warfarin).

The device can fit in a coat pocket and connects wirelessly to clinical networks or a patient’s at-home Bluetooth monitoring application to export test results. It can also connect through a wired Ethernet connection.

The meter assesses how long it takes for a patient’s blood to clot using prothrombin time (PT) and international normalized ratio (INR) tests.

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