FDA grants 510(k) clearance to under-mattress device that assists in OSA diagnosis
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The FDA has granted 510(k) clearance to the Sleep Rx Mat, a clinically validated mat that fits under any mattress and assists in the diagnosis of sleep apnea in adults with suspected sleep breathing disorders, according to a press release.
After sleeping on the Sleep Rx Mat (Withings), the release says that individuals receive information on their sleep, breathing and cardiovascular activity for the night, as well as an “easy-to-understand” sleep quality score.
One notable feature of the device is a pneumatic sensor tracking respiratory rate, body movement, continuous heart rate, sleep cycles, sleep duration and sleep interruptions. Additionally, sound and motion sensors help identify when an individual experiences snoring and breathing disturbances during the night, according to the release.
As Healio previously reported in a study of data from more than 11.6 million nights, 21,573 out of 67,278 adults using Withings Sleep Analyzer had mild OSA, 9,982 had moderate OSA and 5,672 had severe OSA.
The likelihood of misdiagnosis ranged from 20% and 50% based on single night studies, but with more monitoring nights, misdiagnosis error rates went down and remained stable after night 14 of monitoring.
According to the release, individuals need a prescription to obtain the Sleep Rx Mat.
“Enabling earlier and more precise diagnosis, Sleep Rx creates a new sleep apnea diagnosis and management paradigm,” Antoine Robillard, vice president of Withings Health Solutions, said in the release. “We know that a one-night assessment is not sufficient. By enabling more efficient and lower-cost home-based OSA diagnosis, Sleep Rx could not only reduce the staggering $150 billion annual economic burden of undiagnosed sleep apnea but also significantly improve long-term health outcomes.”