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Medical Devices / Submissions and Approvals

VivaQuant’s Wearable ECG Monitor Gains FDA Clearance

May 1, 2019
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The FDA granted VivaQuant 510(k) clearance for its RX-1 product, a wearable electrocardiogram device used to monitor patients for arrhythmia.

Patients wear the device throughout the day and it constantly monitors for abnormal heart rhythms, sending the collected data to an online database.

Staff in a U.S.-based monitoring center review the data transmitted by the device and alert the patient’s physician about any clinically significant information.

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