FDA clears Advanced Brain Monitoring neuro-cardio diagnostic tool

26 September 2012 (Last Updated September 26th, 2012 18:30)

The US Food and Drug Administration (FDA) has granted 510(k) approval to Advanced Brain Monitoring's neuro-cardio diagnostic tool to assess sleep architecture and continuity.

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The US Food and Drug Administration (FDA) has granted 510(k) approval to Advanced Brain Monitoring's neuro-cardio diagnostic tool to assess sleep architecture and continuity.

Sleep Profiler is designed to measure the duration and efficiency of sleep, cortical, sympathetic and behaviour 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 CEO and co-inventor Chris Berka said; "Sleep Profiler incorporates novel technology recognised by the US Patent and Trademark Office."

Advanced Brain Monitoring chief medical officer and American Academy of Sleep Medicine past-president Dr Philip Westbrook said sleep patterns can help differentiate depression from other causes of insomnia and aid 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 said.

"Sleep Profiler metrics can assist researchers achieve the five goals of the 2011 NIH Sleep Disorders Research Plan."

The National Institutes of Health reports that around 25% - 30% of the general adult population suffers from compromises in sleep quality that contribute to disability, morbidity and mortality.

Advanced Brain Monitoring president and study principal investigator Daniel J Levendowski said the device 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 said.


Image:The neuro-cardio diagnostic tool assess the impact of sleep quality management and differentiate sleep state misperceptions. Photo: Courtesy of Business Wire.