CARLSBAD, Calif.--(BUSINESS WIRE)-- Advanced Brain Monitoring, a medical device company focused on developing and commercializing innovative devices for sleep medicine and neurology, announces that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for Sleep Profiler. Sleep Profiler is a patient-friendly neuro-cardio diagnostic tool to assess sleep architecture and continuity.
According to the National Institutes of Health, an estimated 25-30% of the general adult population suffers from compromises in sleep quality which are proven contributors to disability, morbidity and mortality. “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,” stated Dr. Philip Westbrook, Chief Medical Officer, Advanced Brain Monitoring, and Past-President, American Academy of Sleep Medicine. “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.”
“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. “Sleep Profiler metrics can assist researchers achieve the five goals of the 2011 NIH Sleep Disorders Research Plan,” said Dr. Westbrook.
“Sleep Profiler incorporates novel technology recognized by the U.S. Patent and Trademark Office,” stated Chris Berka, CEO and co-inventor. “These innovations are a direct result of our company’s mission to develop products that can be self-applied by the patient and acquire clinical information equivalent to that obtained by more expensive laboratory procedures.”
About Advanced Brain Monitoring
Advanced Brain Monitoring, headquartered in Carlsbad, CA, is a privately held industry leader focused on developing innovative solutions for the diagnosis and treatment of sleep, neurological, and psychiatric disorders. For the past five years the Company was named to the Inc. 5000 fastest-growing U.S. companies. Sleep Profiler is one of several new products introduced by Advanced Brain Monitoring at MEDICA World Forum for Medicine 2012.