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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Friday, October 13, 2023
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Masimo (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.
Key Points:
- Masimo (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.
- View the full release here: https://www.businesswire.com/news/home/20231013679815/en/
Without ORi, there is no noninvasive way to monitor oxygenation under supplemental oxygen to manage hyperoxia, or higher than normal oxygenation of arterial blood. - By convention, SpO2 is limited to an upper limit of 100%, but oxygenation can rise into hyperoxia when supplemental oxygen is administered.