News FDA Clears Advanced Brain Monitoring’s Apnea
Risk Evaluation System (ARES™) for In-Home Diagnosis of Obstructive
Sleep Apnea Advanced Brain Monitoring, Inc. today announced it received marketing clearance from the U.S. Food and Drug Administration (FDA) for its Apnea Risk Evaluation System (ARES). The patented ARES is an easy-to-apply, in-home system for diagnosing obstructive sleep apnea (OSA). The ARES combines a miniaturized, battery-powered device to measure blood oxygen levels, pulse rate, snoring sounds, nasal pressure and head position/movement with a questionnaire to assess known risk factors. A multi-site clinical trial, including direct comparisons with laboratory testing and in-home studies on 280 participants, proved ARES was as accurate as the gold standard laboratory sleep study. View press release. |
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Advanced Brain Monitoring Awarded U.S. Patent
for Apnea Risk Evaluation System (ARES™) Advanced Brain Monitoring has been awarded a U.S. Patent for the Apnea Risk Evaluation System (ARES), designed for in-home diagnosis of obstructive sleep apnea. The patent, entitled “Sleep Apnea Risk Evaluation”, was issued patent number 6,811,538 by the U.S. Patent and Trademark Office. The ARES combines a miniaturized, battery-powered device to measure blood oxygen levels, pulse rate, snoring sounds, nasal pressure and head position/movement with a questionnaire to assess known risk factors. The system includes the first pulse-oximeter designed specifically to characterize sleep-disordered breathing. The patent will be issued on November 2, 2004. |
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International Journal of
Human-Computer Interaction publishes article on Advanced Brain Monitoring's
EEG system Future military and industrial applications of Advanced Brain Monitoring’s EEG system are discussed in the July 2004 issue of the International Journal of Human-Computer Interaction. The article, “Real-Time Analysis of EEG Indices of Alertness, Cognition and Memory Acquired with a Wireless EEG Headset”, presents an integrated solution for mobile acquisition and real-time analysis of the electroencephalogram (EEG) to monitor indices of alertness, cognition and memory. The theme of this special issue of the journal, “Augmented Cognition”, suggests that integration of physiological monitoring into the man-machine interface holds great promise for real-time assessment of operator status and intelligent allocation of tasks between machines and humans. |
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Advanced Brain Monitoring
to present at Sleep Medicine conference Dr. Philip Westbrook, Medical Director of Advanced Brain Monitoring, will present data validating the Apnea Risk Evaluation System (ARES) and the Alertness and Memory Profiling System (AMP) at the Associated Professional Sleep Societies annual meeting in Philadelphia, PA, June 5 – 10. The ARES presentation, “A Limited-Channel Single-Site System to Diagnose Obstructive Sleep Apnea (OSA): Comparison of Full Polysomnography (PSG) with In-home and In-Lab Recordings”, includes data acquired from 270 patients and healthy controls to validate the ARES as a system for diagnosing OSA. The AMP study was designed to identify changes in alertness and memory in response to treatment of OSA with Continuous Positive Airway Pressure (CPAP). The presentation, “Quantification of Alertness, Memory and Neurophysiological Changes in Sleep Apnea Patients Following Treatment with nCPAP”, reports AMP data acquired from over 100 OSA patients and healthy controls studied repeatedly over a 3-month period. |
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Press Releases FDA CLEARS ADVANCED BRAIN MONITORING'S APNEA RISK EVALUATION SYSTEM (ARES™) FOR IN-HOME DIAGNOSIS OF OBSTRUCTIVE SLEEP APNEA CARLSBAD, CALIFORNIA, October 20, 2004 - Advanced Brain Monitoring, Inc. today announced it received marketing clearance from the U.S. Food and Drug Administration (FDA) for its Apnea Risk Evaluation System (ARES). The patented ARES is an easy-to-apply, in-home system for diagnosing obstructive sleep apnea (OSA). The ARES combines a miniaturized, battery-powered device to measure blood oxygen levels, pulse rate, snoring sounds, nasal pressure and head position/movement with a questionnaire to assess known risk factors. A multi-site clinical trial, including direct comparisons with laboratory testing and in-home studies on 280 participants, proved ARES was as accurate as the gold standard laboratory sleep study. "We are very pleased to be able to address the need for diagnosing this highly prevalent, underdiagnosed, potentially life-threatening disorder", Dr. Philip Westbrook, Medical Director of Advanced Brain Monitoring commented, "Untreated sleep apnea can result in daytime drowsiness and memory impairment as well as increased risk of hypertension, diabetes and cardiovascular disease". The National Sleep Foundation estimates that over 18 million Americans have OSA and 90% have not yet been diagnosed. Untreated OSA patients are 3-5 times more likely to be involved in industrial and motor vehicle accidents, due to slower reaction times and impaired vigilance. Chris Berka, Chief Executive Officer of Advanced Brain Monitoring said, "We are excited about the launch of the ARES. There is a growing need for physicians, particularly those in occupational medicine, to have access to a convenient, inexpensive and accurate method for diagnosing OSA and for monitoring the effectiveness of treatment. The ARES is the first of the family of products we are introducing to meet these needs". Advanced Brain Monitoring, Inc. is addressing OSA, memory dysfunction, and alertness monitoring with instrument systems that combine laboratory-level accuracy with the portability, ease-of-use and low cost of consumer electronics. The Company's second product launch, of the AMP (Alertness and Memory Profiler) features wireless EEG monitoring to enable portable, user-friendly brain assessment. The AMP simultaneously measures brain function and cognitive performance during vigilance, attention and memory tests. Alternatively, the EEG systems provide real-time monitoring of alertness and workload to ensure safety and effectiveness in military operations or other high-risk occupations. Advanced Brain Monitoring systems enable widespread use by physicians, dentists, industrial/transportation companies and consumers. |
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