www.fdanews.com/articles/176933-fda-clears-cer%C3%AAves-sleep-system
FDA Clears Cerêve’s Sleep System
June 6, 2016
The FDA has awarded clearance to Pennsylvania-based Cerêve’s sleep system for insomnia.
The device is specifically designed to reduce latency to stage 1 and stage 2 sleep.
Safety and efficacy of the device were demonstrated through three independent clinical studies on more than 230 patients over 3,800 research nights. — Michael Cipriano