Connected health technology company Withings announced that it has received FDA 510(k) clearance for its Sleep Rx Mat, a noninvasive, non-contact device designed to diagnose sleep apnea in the home.
Among the Sleep Rx Mat’s features are pneumatic sensors to measure sleep cycles, duration, and interruptions, along with respiratory rate, body movements, and continuous heart rate, while sound and motion sensors detect snoring and breathing disturbances.
“We are excited to bring Sleep Rx to the U.S. market.” Antoine RobilliardWithings Health Solutions vice president said in a statement.
“By enabling faster, more accurate diagnosis, Sleep Rx creates a new paradigm for sleep apnea diagnosis and management. We know that one assessment is not enough.”
The bigger trend
In 2023 Withings has launched the U-Scan, a biomarker assessment platform that can be placed inside a toilet to monitor personal health through urine analysis. The U-Scan reader comes with a replaceable analysis cartridge that analyzes specific biomarkers in a person’s urine and sends daily insights to the Withings Health Mate app.
In 2022 Medable has partnered with Withing to use the company’s connected devices in decentralized clinical trials. The partnership allowed Withings’ remote monitoring tools (connected scales, blood pressure monitors, sleep tracking mats, etc.) to collect patient data and integrate with Medable’s clinical trial platform.
In the same year, Withings has unveiled a remote patient monitoring program called Withings RPM, which uses the company’s connected devices, such as scales, watches, thermometers, and blood pressure monitors, to monitor patient metrics including heart rate, activity, blood pressure, and sleep patterns.
Dr. Shawn Griffin, URAC’s president and CEO, said Children’s National Hospital, Texas Tech University Health Science Center, Arcare and AbleTo are facilities that are implementing high-quality telemedicine and providing care to underserved populations.
Dr. Shawn Griffin, URAC’s president and CEO, said Children’s National Hospital, Texas Tech University Health Science Center, Arcare and AbleTo are facilities that are implementing high-quality telemedicine and providing care to underserved populations.
