On July 7, 2022, Cerebra Medical announced it received FDA 510(k) clearance for its Cerebra Sleep System, a lab-quality in-home polysomnography (PSG) that is fully self-applied by the patient, without the presence of a technician.
About Cerebra Sleep System
The Cerebra Sleep System is an integrated diagnostic platform that acquires, transmits, analyzes and displays physiological signals from adult patients and then provides scoring (automatic and manual), editing and generating reports.
Using polysomnography, the Cerebra Sleep System records the electroencephalogram (EEG), electrooculogram (EOG), electrocardiogram (ECG), electromyogram (EMG), accelerometry, acoustic signals, nasal airflow, thoracic and abdomen respiratory effort, pulse rate and oxyhemoglobin saturation, depending on the sleep study configuration.
According to the FDA 510(k) summary letter, the Cerebra Sleep System is capable of collecting data required for level 2 PSG and level 3 HSAT studies.
The Cerebra Sleep System is available by prescription and is intended for use at home or in a health care facility. It is intended as a support tool to aid physicians and PSG technologists in the evaluation and diagnosis of sleep disorders.
About sleep disorders
Sleep disorders are conditions that disrupt normal sleep patterns, affecting the quality, amount and timing of sleep. With an estimated 70 million people worldwide experiencing sleep disorders, these conditions can contribute to physical and mental health problems.
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