The U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for Advanced Brain Monitoring’s Sleep Profiler to be used in the diagnosis of sleep apnea. Sleep Profiler is a self-applied system for the assessment of overnight EEG that has historically been used in patients with insomnia or mood disorders. With this clearance, The Sleep Profiler PSG2 can now also be used with patients suspected to have obstructive sleep apnea.
“Sleep Profiler PSG2 meets the requirements for unattended polysomnography, the most accurate method for in-home assessment of sleep-disordered breathing,” says Philip R. Westbrook, MD, chief medical officer of Advanced Brain Monitoring and past‐president of the American Academy of Sleep Medicine, in a release. “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.”