News & Media

FDA Grants 510(k) Clearance to Cerebra Sleep System, the first self-applied PSG system built specifically for in-home use.

Winnipeg, Canada — Cerebra Medical Ltd., a Canadian technology company transforming the future of sleep disorder diagnosis and therapy, 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 drive 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.”




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