www.fdanews.com/articles/176045-sleep-profiler-psg2-garners-fda-clearance
Sleep Profiler PSG2 Garners FDA Clearance
April 6, 2016
The FDA has granted sleep diagnostics company Advanced Brain Monitoring clearance for its Sleep Profiler PSG2, designed to assess overnight electroencephalograms to diagnose sleep apnea in patients experiencing insomnia or mood disorders.
The test measures rapid eye movement associated with obstructive sleep apnea, helps “differentiate sleep state misperception” and can identify a potentially detrimental sleep pattern, according to the company.
Approximately 23.5 million adults in the U.S. suffer from undiagnosed obstructive sleep apnea, according to the American Academy of Sleep Medicine. — Anisa Jibrell