Masimo has received de novo approval from the US Food and Drug Administration (FDA) for ORi, its noninvasive, continuous parameter that delivers additional insight into a patient’s oxygen status in the moderate hyperoxic range under supplemental oxygen.

Leveraging the multi-wavelength Masimo rainbowPulse CO-Oximetry platform, Ori can be used along with oxygen saturation (SpO₂) to offer enhanced resolution of changes in oxygenation under supplemental oxygen.

It is claimed to be the first FDA-approved parameter designed to help clinicians manage the oxygen levels of adult surgical patients in perioperative hospital settings.

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To extend the visibility of the oxygenation of patients beyond SpO₂ under supplemental oxygen, ORi is trended continuously with SpO₂ as a unit-less index between 0.00 and 1.00.

As a convention, SpO₂ is restricted to an upper limit of 100%, but the introduction of supplemental oxygen can elevate oxygenation to hyperoxia levels.

ORi offers real-time insights to clinicians alongside Masimo SET pulse oximetry, indicating whether oxygenation has increased into or dropped out of moderate hyperoxia.