Cerebra Medical Ltd., announced today it has received 510(k) market clearance from the US Food and Drug Administration (FDA) 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. The Cerebra Sleep System has been designed from the ground up for in-home use and offers a truly scalable solution for bringing PSG testing to the home environment. The intuitive tablet interface and detailed instructional videos are key to high study success rates while the ability to wirelessly transfer study results for scoring and review drives operational efficiencies.
“We believe the future of the sleep lab is in the home and that better patient outcomes begin with better diagnosis.” Nicholas Kosciolek, CEO Cerebra Medical. “Now that we have attained FDA market clearance, we can offer the Cerebra Sleep System in the US clinical sleep market and start helping more people get the accurate diagnosis they need to start sleeping better.“
Cerebra is doing more than bringing the sleep lab to the home. At the center of the Cerebra Sleep System is the patented ORP algorithm, highly validated as the most accurate measure of sleep depth (Younes et al., SLEEP 2015). As a key component of Cerebra’s validated autoscoring algorithm, ORP micro analyzes the electroencephalogram (EEG) signal, moving beyond conventional scoring methods to dig deeper into brain activity during sleep enabling physicians to make better-informed diagnosis and treatment.
“ORP is a unique addition to the Cerebra Sleep System that goes beyond conventional measurements, giving clinicians additional insights into a patient’s sleep quality to better inform diagnosis and therapy direction,” says Dr. Amy Bender, Director of Clinical Sleep Science at Cerebra. “ORP architecture has been linked to discoveries related to sleep improvement using CPAP as well as insomnia phenotyping. These two areas alone could transform the field of sleep medicine.”
Cerebra Sleep System was first cleared by Health Canada as a Class II medical device in 2015 and has received four Health Canada clearances in total. It is currently used as the preferred Type II PSG sleep test by many health care providers in Canada.
Source: Cerebra
