FDA clears the first contactless device to aid for sleep apnea diagnosis

Digital health device maker Withings has recently received clearance from the U.S. Food and Drug Administration (FDA) for its innovative Sleep Rx Mat. This device is the first contactless solution aimed at diagnosing sleep apnea, a condition that affects around 30 million adults in the U.S., with an estimated 80% of cases going undiagnosed.

The Sleep Rx Mat offers a non-invasive, accessible, and efficient approach to detecting sleep apnea, marking a new chapter in the management of this widespread yet often overlooked health issue.

How does it work?

The Sleep Rx Mat is designed for home use and offers a simple, unobtrusive way to screen for sleep apnea and monitor sleep patterns. Placed under any mattress, the mat uses advanced sensors to track various physiological parameters such as respiratory rate, body movement, heart rate, sleep cycles, and interruptions — as well as detecting snoring and other breathing disturbances. These data points are crucial indicators of sleep apnea.

Unlike traditional methods that require an overnight stay in a sleep lab, the Sleep Rx Mat provides continuous, longitudinal data over multiple nights — offering a more comprehensive understanding of a patient's sleep health.

It is available by prescription for clinical use or as part of remote patient monitoring programs, thus bridging the gap between patients and healthcare providers.

Why does it matter?

The clearance of the Sleep Rx Mat by the FDA is a major advancement in the early diagnosis of sleep apnea, a condition that is linked to numerous cardiometabolic risks — including diabetes, hypertension, stroke, and heart disease. Traditional diagnostic methods, like polysomnography (PSG), are often costly, inconvenient, and limited in availability, which contributes to the high rate of undiagnosed cases.

With its ability to provide a detailed analysis of sleep quality and detect apnea episodes without the need for cumbersome equipment, the Sleep Rx Mat addresses these limitations, potentially reducing the estimated $150 billion economic burden of untreated sleep apnea in the U.S.

"Enabling earlier and more precise diagnosis, Sleep Rx creates a new sleep apnea diagnosis and management paradigm," said Antoine Robiliard, VP of Withings Health Solutions.

The context

Sleep apnea remains a critical yet underdiagnosed public health concern, affecting millions of adults worldwide. The traditional diagnostic approach, which often involves a single-night assessment in a sleep lab, is expensive and may lead to significant diagnostic inaccuracies. As research indicates, the severity of obstructive sleep apnea can vary greatly from night to night, leading to potential misclassifications.

The Withings Sleep Rx Mat is set to revolutionize this process by offering a more scalable, affordable, and accurate home-based diagnostic tool.

This development aligns with Withings' ongoing mission to advance digital health solutions and improve patient outcomes by leveraging technology to provide medical-grade data directly to healthcare professionals.