HomeNewsWithings Sleep Rx Mat receives FDA 510(ok) clearance

Withings Sleep Rx Mat receives FDA 510(ok) clearance

Linked well being know-how firm Withings introduced it has obtained FDA 510(ok) clearance for its Sleep Rx Mat, a noninvasive, contactless system designed to diagnose sleep apnea at house.

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 deliver 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 just isn’t ample.”

THE LARGER TREND

In 2023, Withings launched U-Scan, a biomarker-assessment platform that may be positioned inside a bathroom 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 each day.

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

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That very same 12 months, Withings unveiled a distant patient-monitoring program referred to as Withings RPM, which makes use of the corporate’s related gadgets, equivalent to scales, watches, thermometers and blood strain cuffs to observe affected person metrics, together with coronary heart fee, exercise, blood strain and sleep patterns.

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

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