Masimo ORi™ Granted De Novo as the First and Only FDA-Cleared Noninvasive and Continuous Parameter to Provide Insight into Hyperoxia Under Supplemental Oxygen

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[{"type":"text","content":"\nORi to Be Launched in the U.S. at ANESTHESIOLOGY 2023 This Weekend\n\n\n SAN FRANCISCO--(BUSINESS WIRE)--\nMasimo (NASDAQ: MASI) today 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.\n\nThis press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20231013679815/en/Masimo ORi™ (Photo: Business Wire)\nWithout 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.1 Currently, clinicians take blood draws that are analyzed to determine PaO2 levels, the partial pressure of oxygen measured by arterial blood gas devices. However, arterial blood analyses are both intermittent and delayed – leaving clinicians blind to the changes in oxygenation occurring between blood draw results.\n\n\nMasimo ORi addresses these shortcomings by providing continuous insight into the oxygenation of hemoglobin in the moderate hyperoxic range (PaO2 > 100 and ≤ 250 mmHg). ORi is trended continuously with SpO2 as a unit-less index between 0.00 and 1.00 to extend the visibility of the oxygenation of patients beyond SpO2 under supplemental oxygen. By convention, SpO2 is limited to an upper limit of 100%, but oxygenation can rise into hyperoxia when supplemental oxygen is administered. ORi provides clinicians with additional visibility, as a complement to Masimo SET® pulse oximetry, into when oxygenation is increased into, or decreased out of, moderate hyperoxia, in real time.\n\n\nNumerous studies have demonstrated ORi’s utility. For example, in a study published in Anesthesia & Analgesia of 106 adult ...

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