Onera Health announces that the quality management system of its legal manufacturing subsidiary, Onera B.V., has been certified to meet the requirements of MDR (EU) 2017/745 regulation (Annex IX, chapter I and III).. The Onera STS 2 system, which will be marketed as part of the Onera hPSG® solution, falls within […]
Tag: MEDICAL DEVICES
LivaNova Shares Positive 12-Month Results From Obstructive Sleep Apnea Study
Recently published study results demonstrate the efficacy of LivaNova Plc’s aura6000 System in treating moderate to severe obstructive sleep apnea (OSA). Published in Annals of Internal Medicine, the full 12-month results from the company’s OSPREY randomized controlled trial (RCT) demonstrate the safety and efficacy of proximal hypoglossal nerve stimulation (pHGNS), a differentiated neurostimulation modality. Overall, the study authors concluded that pHGNS for OSA yielded clinically significant improvements versus […]





