Data from this study demonstrates that the Onera STS is faster to apply than traditional PSG and provides comparable clinical information. The reduced set-up time and simplified process lower the burden on sleep technicians and have the potential to reduce overall operational costs of PSG. Overall reliability and diagnostic accuracy for sleep stages and sleep parameters were high, suggesting comparable outcomes to in-lab PSG.
FDA 510k cleared and CE-marked refers to the Onera Sleep Test System, which is a Class IIa medical device. Onera STS includes the Onera STS I System, which is CE marked in Europe, and the Onera STS System, which was cleared the the Food and Drug Administration for use in the United States.