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Advanced Brain neuro-cardio diagnostic tool wins FDA nod

Advanced Brain Monitoring has obtained 510(k) clearance for its neuro-cardio diagnostic tool from the US Food and Drug Administration (FDA).

By utilizing technology recognized by the USPTO, Sleep Profiler measures duration and efficiency of sleep, cortical, sympathetic and behavior arousals, intensity and frequency of snoring as well as patterns and density of slow-wave-sleep (SWS) and rapid-eye-movement (REM) sleep.

Advanced Brain Monitoring chief medical officer and American Academy of Sleep Medicine past-president Dr. Philip Westbrook said research has shown that sleep patterns can help differentiate depression from other causes of insomnia and provide biomarkers for early detection of diabetes and hypertension.

"Sleep Profiler provides clinicians a powerful new tool to objectively assess the impact of sleep quality management on chronic diseases, and differentiate sleep state misperception from insomnia and circadian rhythm sleep disorders," Westbrook added.

Around 25-30% of the adult population suffer from compromises in sleep quality which contribute to disability, morbidity and mortality, reports the National Institutes of Health.

Advanced Brain Monitoring president and study principal investigator Daniel J. Levendowski said Sleep Profiler includes automated sleep staging, an important feature validated in a recent peer-reviewed 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," Levendowski added.