Advanced Brain Monitoring wins FDA nod for Sleep Profiler PSG2

Sleep and neurological disorder device developer Advanced Brain Monitoring said today it won FDA 510(k) clearance for its Sleep Profiler PSG2 overnight EEG designed for to diagnose sleep apnea.

The Carlsbad, Calif.-based company said the Sleep Profiler PSG2 is designed to allow for objective evaluation of sleep patterns and home assessment of rapid eye movement related to obstructive sleep apnea.

“Sleep Profiler PSG2 meets the requirements for unattended polysomnography, the most accurate method for in-home assessment of sleep-disordered breathing. 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,” chief medical officer Dr. Philip Westbrook said in prepared remarks.

Advanced Brain Monitoring said a study result from its Sleep Profiler can be used to identify patients with abnormal sleep duration and efficiency, decreased slow wave sleep and increased cortical arousals. These factors are associated with hypertension, obesity, diabetes and memory impairment, the company said.

“Sleep Profiler includes automated sleep staging. Results showed the Sleep Profiler accuracy in detection of REM sleep and slow wave sleep was equivalent to manual scorers from different sleep laboratories,” Advanced Brain Monitoring prez and principal investigator Daniel Levendowski said in a press release.

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