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.
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.
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Masimo founder and CEO Joe Kiani said: “Since ORi’s availability and success outside the US, perioperative clinicians in the US have been waiting for a way to noninvasively monitor patients under supplemental oxygen beyond the limits of SpO₂.
“We are thrilled that US clinicians can now integrate ORi monitoring – available now on our rainbow SETplatform platform – into their oxygenation monitoring practices, alongside Masimo SETMeasure through Motion and Low Perfusion pulse oximetry and experience their combined benefits.”
With de novo approval, the company is launching a new sensor line, RD rainbow4λ sensors, as part of its RD family of pulse CO-oximetry sensors.
The senor line now consists of RD SET, RD rainbow 4λ, RD rainbow 8λ and RD rainbow 12λ.