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…