www.fdanews.com/articles/192149-resoneas-sleep-apnea-screening-app-grabs-fda-clearance
Resonea’s Sleep Apnea Screening App Grabs FDA Clearance
July 26, 2019
Resonea has earned 510(k) clearance for its smartphone-based screening app, Drowzle Sleep Apnea Pre-screening Device, for detecting moderate and severe obstructive sleep apnea (OSA).
Drowzle is designed for at-home use and collects symptom data related to sleep apnea risk, including the user’s level of daytime sleepiness and their chronic disease risk factors.
The app performs its in-home screening without the use of any sensors and is designed for ease of use. It also records sleep breathing patterns and uploads them to a secure cloud server for analysis.