FDA approves use of Masimo’s oxygen saturation reading device

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Masimo has won US Food and Drug Administration (FDA) clearance for its Rad-G pulse oximeter, a rugged device developed with the help of The Bill & Melinda Gates Foundation. Medgadget reports that originally created to spot-check patients for SpO2 (oxygen saturation), respiration rate from the plethysmograph (RRp), pulse rate (PR), perfusion index (Pi), and pleth variability index (PVi®), this latest generation of the Rad-G allows for continuous monitoring as well.

Thanks to the new Rad-G sensor, the oximeter can be used on both adults and children, allowing the same device to be used on all patients without having to switch the sensor. However, the Rad-G can use any of Masimo’s other disposable or reusable patient sensors, so its applications go beyond what initially comes in the box.

The batteries inside the device allow it to work continuously for 24 hours, something particularly useful for emergency response, field applications, and in low-resource settings where electricity may not be available.

A rubber wrapping protects the Rad-G from damage and because it’s light and compact it can be taken and used just about anywhere, including field emergencies, physician offices, long-term care facilities, and outpatient settings. Clinicians can set audible alarms and monitor the continuous pleth waveform on the high-resolution display, as well as check the other patient parameters that the device can keep track of.

“With the Rad-G Pulse Oximeter, we set out to create an accessible, high-quality care solution that clinicians can rely on in a multitude of care settings,” said Joe Kiani, CEO of Masimo. “We are bringing our expertise in pulse oximetry to a smaller, more lightweight, rugged, and versatile handheld device – without sacrificing any of the advantages that help provide clinicians with critical insights into patient status. As the COVID-19 pandemic continues, it’s more imperative than ever that caregivers have access to the most accurate and reliable pulse oximetry monitoring technologies. We are proud to offer Rad-G among our suite of solutions powered by the breakthrough technology, SET® pulse oximetry.”

 

Medgadget material

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