On Sept. 9, 2024, Withings announced that it received FDA 510(k) clearance for its Sleep Rx mat, a contactless device for diagnosing obstructive sleep apnea (OSA).
About Sleep Rx
Sleep Rx is an under-the-mattress device intended to aid in the diagnosis of OSA at home. The mat provides analysis of sleep, breathing and cardiovascular activity.
Using a pneumatic sensor, Sleep Rx measures respiratory rate, body movement and heart rate. It also tracks sleep cycles, duration and interruptions. Sound and motion sensors detect snoring and breathing disturbances, indicators of OSA. The device then provides a sleep quality score to users for assessment of their rest.
According to the company’s press release, Sleep Rx is clinically validated for use in home screening of adults with suspected sleep breathing disorders. The device represents a lower-cost, home-based alternative to gold-standard polysomnography.
Sleep Rx is available in the U.S. by prescription as part of clinical sleep management or remote patient monitoring programs.
About OSA
OSA is a prevalent and serious sleep disorder where the airway becomes repeatedly blocked during sleep, leading to paused breathing and oxygen deprivation. Commonly caused by the collapse of throat tissues, it can result in loud snoring, choking noises and frequent awakenings, potentially contributing to health issues such as high blood pressure, heart disease, stroke, diabetes and depression.
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