FDA Clears Masimo Rad-G Pulse Oximeter

The US Food and Drug Administration has cleared Masimo’s Rad-G Pulse Oximeter, a handheld device that provides SET pulse oximetry, respiration rate from the pleth, and other vital parameters for both spot-checking and continuous monitoring. It features a new direct-connect sensor.

Launching alongside the device, the new multipurpose, direct-connect Rad-G Sensor is indicated for monitoring both adult and pediatric patients. It eliminates the need to stock and carry multiple sensor types. Rad-G is compatible with the vast portfolio of Masimo reusable and single-patient-use sensors.

First developed in partnership with The Bill & Melinda Gates Foundation as a spot-check device for global use, the 2021 Rad-G expands on its predecessor’s capabilities with the addition of alarms. Rad-G’s rechargeable battery provides 24 hours of use between charges. The high-resolution screen displays a continuous pleth waveform and its fully configurable, audible alarms help alert clinicians to changes in patient status that may require their intervention.

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Rad-G allows for the same sensor to be used to monitor respiration rate from the plethysmograph, with RRp. With breathing difficulty generally considered one of the earliest signs of patient deterioration, Masimo hopes that the availability of RRp on Rad-G may play a role in assisting clinicians and public health officials as they seek to combat respiratory-related illnesses, including pneumonia and COVID-19.

Joe Kiani, founder and CEO of Masimo, says in a release, “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. 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.”

from Sleep Review https://ift.tt/34DlQkq