October 16, 2023- Masimo announced that Ori, a noninvasive, continuous parameter designed to provide additional insight into a patient’s oxygen status in the moderate hyperoxic range under supplemental oxygen, has been granted a De Novo by the FDA.
Enabled by the multi-wavelength Masimo rainbow® Pulse CO-Oximetry platform, ORi is designed for use in conjunction with oxygen saturation (SpO2) to provide increased resolution of changes in oxygenation under supplemental oxygen. With the De Novo, ORi becomes the first-of-its-kind parameter cleared by the FDA to help clinicians manage oxygen of adults undergoing surgery in perioperative hospital environments.
Without ORi, there is no noninvasive way to monitor oxygenation under supplemental oxygen to manage hyperoxia, or higher than normal oxygenation of arterial blood. There is growing evidence that hyperoxia is harmful and can lead to oxygen toxicity, causing oxygen poisoning or pulmonary tissue damage.