MetaMedical™ Solutions Inc

Masimo gets de novo approval from FDA for ORi

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.

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