On Sept. 9, 2024, Withings introduced that it obtained FDA 510(okay) clearance for its Sleep Rx mat, a contactless machine for diagnosing obstructive sleep apnea (OSA).
About Sleep Rx
Sleep Rx is an under-the-mattress machine supposed to help within the prognosis of OSA at dwelling. The mat offers evaluation of sleep, respiratory and cardiovascular exercise.
Utilizing a pneumatic sensor, Sleep Rx measures respiratory fee, physique motion and coronary heart fee. It additionally tracks sleep cycles, period and interruptions. Sound and movement sensors detect loud night breathing and respiratory disturbances, indicators of OSA. The machine then offers a sleep high quality rating to customers for evaluation of their relaxation.
In keeping with the corporate’s press launch, Sleep Rx is clinically validated to be used in dwelling screening of adults with suspected sleep respiratory issues. The machine represents a lower-cost, home-based various to gold-standard polysomnography.
Sleep Rx is on the market within the U.S. by prescription as a part of medical sleep administration or distant affected person monitoring packages.
About OSA
OSA is a prevalent and critical sleep problem the place the airway turns into repeatedly blocked throughout sleep, resulting in paused respiratory and oxygen deprivation. Generally brought on by the collapse of throat tissues, it can lead to loud loud night breathing, choking noises and frequent awakenings, doubtlessly contributing to well being points resembling hypertension, coronary heart illness, stroke, diabetes and despair.
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