510(k) Clearance Granted To ResApp Sleep Apnea Detection App
The US Food and Drug Administration has granted clearance to ResApp Health’s 510(k) app. The SleepCheckRx app screens users for moderate to severe sleep apnea by listening to recordings of their breathing and snoring. The regulatory clearance will only apply to the iPhone version. However, ResApp has stated that they are committed to developing an android version. In the U.S. alone, approximately 20 million American adults live with sleep apnea. Despite the high number, the majority are unaware of their condition. The new app will help provide physicians with the opportunity to evaluate their patients effectively. To acquire access to…