The Onera wireless patch-based PSG system is an easy solution for sleep studies at home or in the sleep lab, lowering the burden to conduct sleep studies. The presence of standard EEG signals allows to determine NREM and REM statistics, respiratory and non-respiratory arousal indices, AHI and RERA’s by sleep stages. Preliminary study results show that using cortical arousal criteria for hypopneas, the AHI increase is more pronounced in NREM compared to REM sleep.
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.