Withings Sleep Rx Mat receives FDA 510(k) clearance

Connected health technology company Withings announced it has received FDA 510(k) clearance for its Sleep Rx Mat, a noninvasive, contactless device designed to diagnose sleep apnea at home.

Among the Sleep Rx Mat features, a pneumatic sensor measures respiratory rate, body movement and continuous heart rate, along with sleep cycles, duration and interruptions, while sound and motion sensors detect snoring and breathing disturbances.

“We’re thrilled to bring Sleep Rx to the U.S. market,” Antoine Robiliard, vice president of Withings Health Solutions, said in a statement.

“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.”

THE LARGER TREND

In 2023, Withings launched U-Scan, a biomarker-assessment platform that can be placed inside a toilet bowl to monitor an individual’s health using urine analysis. The U-Scan reader comes with changeable analysis cartridges that analyzes a person’s urine for specific biomarkers and sends insights to the Withings Health Mate app daily.

In 2022, Medable partnered with Withing to use the company’s connected devices for decentralized clinical trials. The alliance allowed Withings’ tools for remote monitoring, like connected scales, blood pressure monitors and sleep-tracking mats to collect patient data and integrate with Medable’s clinical trial platform. 

That same year, Withings unveiled a remote patient-monitoring program called Withings RPM, which utilizes the company’s connected devices, such as scales, watches, thermometers and blood pressure cuffs to monitor patient metrics, including heart rate, activity, blood pressure and sleep patterns.

Children’s National Hospital, Texas Tech University Health Sciences Center, Arcare and AbleTo are facilities practicing quality telemedicine and delivering care to underserved populations, says Dr. Shawn Griffin, president and CEO at URAC.

Children’s National Hospital, Texas Tech University Health Sciences Center, Arcare and AbleTo are facilities practicing quality telemedicine and delivering care to underserved populations, says Dr. Shawn Griffin, president and CEO at URAC.