Withings, a global leader in connected health technology, has announced that its innovative Sleep Rx Mat has received clearance from the U.S. Food and Drug Administration (FDA). This is a significant development, as Sleep Rx is the first contactless device approved to help diagnose sleep apnea in patients. Sleep apnea is a sleep disorder that affects millions of people and is often underdiagnosed due to the limitations of traditional methods. With the launch of Sleep Rx in the U.S., Withings aims to address these challenges, making it easier for patients to receive accurate diagnoses and improve their health.
Tackling the Sleep Apnea Crisis
Sleep apnea, especially obstructive sleep apnea (OSA), affects around 30 million adults in the U.S., but about 80% of cases go undiagnosed. This means millions of people are suffering from a condition that can cause serious health issues, such as heart disease, stroke, and diabetes, without even knowing it. Traditional diagnostic methods like polysomnography (PSG) involve overnight stays in sleep labs, which are costly, uncomfortable, and sometimes inaccurate. This has created a barrier for many people to get the diagnosis and treatment they need.
Sleep Rx offers a new, less intrusive way to detect sleep apnea. Antoine Robiliard, VP of Withings Health Solutions, said, “We’re thrilled to bring Sleep Rx to the U.S. market. By enabling earlier and more precise diagnosis, Sleep Rx creates a new sleep apnea diagnosis and management paradigm.” He also highlighted that this technology could help reduce the $150 billion economic burden caused by undiagnosed sleep apnea in the U.S.
How Sleep Rx Works
Sleep Rx is a state-of-the-art, contactless mat that fits underneath a mattress and requires only a one-time setup. Unlike other sleep apnea diagnostic tools, Sleep Rx does not require patients to wear masks or be connected to machines overnight. Once placed under the mattress, the device tracks sleep, breathing patterns, and cardiovascular activity throughout the night. It uses advanced sensors to monitor respiratory rate, heart rate, snoring, and body movement. These factors are key indicators of sleep apnea, and the device provides a comprehensive sleep quality score every morning.
Because Sleep Rx can be used over an extended period of time, it gives doctors a clearer picture of a patient’s condition, addressing one of the limitations of single-night PSG tests. By analyzing data from multiple nights, Sleep Rx helps provide a more accurate diagnosis, which is essential for OSA, a condition where symptoms can vary night to night.
Revolutionizing Diagnosis with Advanced Technology
One of the most impressive features of Sleep Rx is its ability to gather medical-grade data without inconveniencing the patient. It uses a pneumatic sensor to track a wide range of sleep and cardiovascular metrics, while sound and motion sensors detect disturbances in breathing and snoring. All of this data is processed through the device’s advanced algorithms, providing a detailed report for healthcare professionals to review.
Sleep Rx is available by prescription and can be used in both clinical settings and remote patient monitoring programs. This makes it easier for doctors to monitor patients with suspected sleep apnea without requiring them to visit a sleep lab.
A Game-Changer in the Sleep Apnea Journey
Global studies show that Sleep Rx can transform how patients are diagnosed and treated for sleep apnea. Long-term data collected from devices like Sleep Rx have shown the importance of monitoring patients over time, rather than relying on a single-night assessment. A study involving more than 11 million nights of sleep data, conducted by Flinders Health and Medical Research Institute, revealed that sleep apnea symptoms fluctuate significantly from night to night. This highlights the need for longer-term monitoring, something Sleep Rx offers effortlessly.
With Sleep Rx, patients can now be diagnosed more accurately, allowing healthcare professionals to prescribe treatments sooner and improve outcomes. This is crucial, as untreated sleep apnea increases the risk of serious health conditions like heart attacks, strokes, and diabetes.
What This Means for the Future of Sleep Health
The FDA clearance of Sleep Rx marks a significant step forward in sleep health technology. As Antoine Robiliard emphasized, the device offers a “more efficient and lower-cost home-based OSA diagnosis,” which will not only ease the burden on sleep clinics but also improve long-term health outcomes for millions of people. By making sleep apnea diagnosis easier, more accurate, and accessible from home, Withings is paving the way for better health outcomes across the U.S.
With Sleep Rx, Withings is continuing its mission to use technology to improve health outcomes. Known for its smart health devices like scales and blood pressure monitors, Withings has once again pushed the boundaries of what connected health devices can achieve.
For more information about Sleep Rx and Withings’ ongoing health innovations, visit Withings Health Solutions.
