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# FDA Clears Advanced Brain’s Sleep Profiler
- URL: https://www.fdaweb.com/fda-clears-advanced-brains-sleep-profiler/
- Published: 2016-04-06T12:00:00.000Z
- Updated: 2026-09-14T20:53:04.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5135295

> FDA has cleared an Advanced Brain Monitoring 510(k) for its [Sleep Profiler](http://www.advancedbrainmonitoring.com/sleep-profiler-psg2/?ref=fdaweb.com), an overnight sleep monitor and [electroencephalogram](http://cts.businesswire.com/ct/CT?id=smartlink&url=http%3A%2F%2Fwww.sleepreviewmag.com%2F2016%2F03%2Fobjective-eeg-monitoring-insomnia%2F&esheet=51314087&newsitemid=20160406005204&lan=en-US&anchor=overnight+EEG&index=2&md5=156e23e835ce52702c8de4ba0856d6ca&ref=fdaweb.com) for patients with insomnia or mood disorders that is intended for diagnosing sleep apnea. “Clinical study results, required for FDA clearance, showed the Sleep Profiler PSG2 delivers unparalleled accuracy in the automated detection of sleep stage-dependent mild and moderate sleep apnea,” the company says.“ A Sleep Profiler PSG2 study result can identify patients with abnormal sleep duration and efficiency, decreased slow wave sleep, and increased cortical arousals, factors which have been associated with increased hypertension, obesity, diabetes, and memory impairment.” The device is strapped to the head and includes electrodes on the fingers, chest and torso for monitoring sleep patterns.