Masimo Announces FDA Clearance of the Rad-G™ Pulse Oximeter

Masimo Rad-G™ Pulse Oximeter (Photo/Business Wire)

Masimo announced today FDA clearance of the Rad-G™ Pulse Oximeter, a rugged handheld device that provides clinically proven SET® pulse oximetry, respiration rate from the pleth (RRp®), and other vital parameters for both spot-checking and continuous monitoring.

With its long-lasting rechargeable battery, robust rubber casing, light weight, and a convenient new direct-connect sensor capable of monitoring both adults and children, Rad-G makes it easier for clinicians to quickly assess patients and make informed care decisions anywhere pulse oximetry or vital signs checking is needed in a compact, portable form factor.

Providing the ultimate in handheld versatility, Rad-G can be used in a variety of settings, including but not limited to physicians’ offices, outpatient services, long-term care facilities, wellness clinics, first-response scenarios and limited-resource environments.

Launching alongside the device, the new multipurpose, direct-connect Rad-G Sensor is indicated for monitoring both adult and pediatric patients. By eliminating the need to stock and carry multiple sensor types, the Rad-G Sensor further increases Rad-G’s versatility and ease of use, especially in more challenging field environments.

In addition to this innovative new sensor, Rad-G is compatible with the vast portfolio of Masimo reusable and single-patient-use sensors, maximizing its flexibility and offering clinicians the ability to customize the solution based on the unique needs of each care setting.

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 and thus the ability to provide continuous monitoring – without sacrificing any portability, convenience, or ruggedness.

Rad-G’s rechargeable battery provides an impressive 24 hours of use between charges, allowing clinicians to work in outdoor, transport, and emergency scenarios with confidence that Rad-G will continue to function hour after hour.

All the while, 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.

In addition to Masimo SET® oxygen saturation (SpO2), pulse rate (PR), perfusion index (Pi), and pleth variability index (PVi®), Rad-G is also notable for its ability to use the same sensor 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.

SpO2 and PR monitoring on Rad-G is provided using clinically proven Masimo SET® Measure-through Motion and Low Perfusion™ pulse oximetry, which has been shown in over 100 independent and objective studies to outperform other technologies.1

SET® is estimated to be used on more than 200 million patients a year2 and is the primary pulse oximetry at 9 of the 10 hospitals that top the 2020-21 U.S. News and World Report Best Hospitals Honor Roll.

With Masimo SET® technology in Rad-G, clinicians have access to hospital-grade, accurate pulse oximetry measurements in the palm of their hands.

Joe Kiani, founder and CEO of Masimo, said: “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.”

References

  1. Published clinical studies on pulse oximetry and the benefits of Masimo SET® can be found on our website at http://www.masimo.com. Comparative studies include independent and objective studies which are comprised of abstracts presented at scientific meetings and peer-reviewed journal articles.
  2. Estimate: Masimo data on file.
  3. http://health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview.
  4. Castillo A et al. Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and SpO2 Technology. Acta Paediatr. 2011 Feb;100(2):188-92.
  5. de-Wahl Granelli A et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009;Jan 8;338.
  6. Taenzer AH et al. Impact of pulse oximetry surveillance on rescue events and intensive care unit transfers: a before-and-after concurrence study. Anesthesiology. 2010:112(2):282-287.
  7. Taenzer A et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
  8. McGrath SP et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302.
  9. McGrath S et al. Inpatient Respiratory Arrest Associated With Sedative and Analgesic Medications: Impact of Continuous Monitoring on Patient Mortality and Severe Morbidity. J Patient Saf. 2020 14 Mar. DOI: 10.1097/PTS.0000000000000696.

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