Withings, a global leader in connected health, announces that its Sleep Rx Mat has received clearance from the U.S. Food and Drug Administration. Sleep Apnea is not only severely underdiagnosed worldwide – but also diagnosed using solutions that have shown limitations, in both access and accuracy. By addressing these challenges, the release of Sleep Rx in the US will mark a new era in sleep apnea diagnosis, paving the way to better health outcomes for millions of adults in the US.
Addressing The Growing and Underdiagnosed Sleep Apnea Crisis
Obstructive Sleep Apnea (OSA) affects approximately 30 million adults in the U.S., with a staggering 80% of cases going undiagnosed1. Traditional diagnostic methods, such as Polysomnography (PSG), are limited to diagnosing only the most severe sleep disorders due to their low availability and high cost. PSG is also bulky and intrusive2, requiring an overnight stay in a sleep lab, which many patients find inconvenient. Moreover, a single-night assessment may not accurately represent the severity of OSA, as it can fluctuate from night to night, leading to potential error rates of up to 50%3.
The underdiagnosis of OSA is highly problematic because untreated OSA significantly increases cardiometabolic risks, including diabetes mellitus4, resistant hypertension5, atrial fibrillation6, stroke, and myocardial infarction7.
“We’re thrilled to bring Sleep Rx to the U.S. market,” said Antoine Robiliard, VP of Withings Health Solutions. “Enabling earlier and more precise diagnosis, Sleep Rx creates a new sleep apnea diagnosis and management paradigm. We know that a one-night assessment is not sufficient. By enabling more efficient and lower-cost home-based OSA diagnosis, Sleep Rx could not only reduce the staggering $150 billion annual economic burden of undiagnosed sleep apnea but also significantly improve long-term health outcomes.”
Advanced Sleep Insights at Home
Sleep Rx is an advanced sleep device clinically validated for use in home screening of adults with suspected sleep breathing disorders as an aid for diagnosis of OSA, sleep analysis, and heart rate estimation. The sleek, unobtrusive mat requires a one-time set up, fits under any mattress, eliminating the need for masks or cumbersome equipment. Once set up, it provides detailed analysis of sleep, breathing, and cardiovascular activity throughout the night.
Available in the U.S. by prescription as part of clinical sleep management or remote patient monitoring programs, Sleep Rx can be acquired by healthcare professionals through Withings Health Solutions. It represents a major advancement in the early diagnosis of sleep apnea, using a pneumatic sensor to measure respiratory rate, body movement, and continuous heart rate, along with tracking sleep cycles, duration, and interruptions. Sound and motion sensors detect snoring and breathing disturbances, key indicators of sleep apnea. Each morning, Sleep Rx provides a comprehensive sleep quality score, giving patients an easy-to-understand assessment of their rest.
Revolutionizing Sleep Apnea Patient Journey
Global studies have shown Sleep Rx’s potential to impact every step of the patient’s journey from diagnosis3 to treatment efficacy8. By offering a scalable, accurate, and comprehensive diagnostic solution, Sleep Rx is set to profoundly improve the lives of millions of Americans. As a non-intrusive solution, Sleep Rx can provide longitudinal data. This is a game changer, given that a study of over 11 million nights by Flinders Health and Medical Research Institute using Withings Sleep tracking mats revealed significant variability in the apnea-hypopnea index (AHI) from night to night, highlighting the need for longer-term follow-up—something Sleep Rx now makes possible3.
Availability
Sleep Rx is now available in the U.S. by prescription. For more information about Sleep Rx and Withings’ ongoing commitment to digital health innovation, visit www.withingshealthsolutions.com/connected-devices/sleep-rx.
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