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Withings Sleep Rx Mat receives FDA 510(k) clearance

September 17, 2024
in Health
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Related well being expertise firm Withings introduced it has obtained FDA 510(ok) clearance for its Sleep Rx Mat, a noninvasive, contactless gadget designed to diagnose sleep apnea at dwelling.

Among the many Sleep Rx Mat options, a pneumatic sensor measures respiratory fee, physique motion and steady coronary heart fee, together with sleep cycles, period and interruptions, whereas sound and movement sensors detect loud night breathing and respiratory disturbances.

“We’re thrilled to carry Sleep Rx to the U.S. market,” Antoine Robiliard, vice chairman of Withings Well being Options, mentioned in a press release.

“Enabling earlier and extra exact prognosis, Sleep Rx creates a brand new sleep apnea prognosis and administration paradigm. We all know {that a} one-night evaluation will not be enough.”

THE LARGER TREND

In 2023, Withings launched U-Scan, a biomarker-assessment platform that may be positioned inside a rest room bowl to observe a person’s well being utilizing urine evaluation. The U-Scan reader comes with changeable evaluation cartridges that analyzes an individual’s urine for particular biomarkers and sends insights to the Withings Well being Mate app every day.

In 2022, Medable partnered with Withing to make use of the corporate’s linked units for decentralized scientific trials. The alliance allowed Withings’ instruments for distant monitoring, like linked scales, blood stress screens and sleep-tracking mats to gather affected person information and combine with Medable’s scientific trial platform.

That very same yr, Withings unveiled a distant patient-monitoring program known as Withings RPM, which makes use of the corporate’s linked units, akin to scales, watches, thermometers and blood stress cuffs to observe affected person metrics, together with coronary heart fee, exercise, blood stress and sleep patterns.

Kids’s Nationwide Hospital, Texas Tech College Well being Sciences Heart, Arcare and AbleTo are services working towards high quality telemedicine and delivering care to underserved populations, says Dr. Shawn Griffin, president and CEO at URAC.

Kids’s Nationwide Hospital, Texas Tech College Well being Sciences Heart, Arcare and AbleTo are services working towards high quality telemedicine and delivering care to underserved populations, says Dr. Shawn Griffin, president and CEO at URAC.



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