Advanced Brain Monitoring of Carlsbad, California received FDA 510(k) clearance for its Sleep Profiler professional sleep monitoring device. Used by patients at home to record their sleeping patterns for later review by clinicians, the Sleep Profiler features a 3 channel frontal EEG and can optionally be used along with an ECG unit.
It also records head position and movement, listens for storing, and connects to a computer via USB to dump up to 16 hours of stored data.
From the press release:
“Sleep Profiler includes automated sleep staging, an important feature validated in a recent peer-reviewed study,” stated Daniel J. Levendowski, President and principal investigator of the study. “Results showed the Sleep Profiler accuracy in detection of slow-wave-sleep (SWS) and rapid-eye-movement (REM) sleep was the same as manual scorers from different sleep laboratories.” Sleep Profiler measures sleep duration and sleep efficiency, patterns and density of SWS and REM, cortical, sympathetic and behavior arousals, and frequency and intensity of snoring.
Product page: Sleep Profiler…