Withings gets clearance for home sleep screening device
By HME News Staff
Updated 8:06 AM CDT, Tue September 10, 2024
BOSTON – Withings has announced that its Sleep Rx Mat has received clearance from the U.S. Food and Drug Administration, marking a new era in sleep diagnosis and paving the way to better health outcomes for millions of adults in the United States, the company says. Sleep Rx is an advanced sleep device clinically validated for use in the home screening of adults with suspected sleep breathing disorders as an aid for diagnosis for OSA, sleep analysis and heart rate estimation. The mat requires a one-time set up and fits under any mattress, eliminating the need for masks or other equipment. Once set up, it provides detailed analysis of sleep, breathing and cardiovascular activity throughout the night. The mat is available in the U.S. by prescription as part of clinical sleep management or remote patient monitoring programs. It can be acquired by health care professionals through Withings Health Solutions. FMI: www.withingshealthsolutions.com/connected-devices/sleep-rx.
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