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

September 28, 2020

Rugged Handheld Device Provides Clinically Proven Masimo SET^® Pulse Oximetry and Respiration Rate Monitoring

IRVINE, Calif.--(BUSINESS WIRE)-- Masimo (NASDAQ: MASI) 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 andchildren, 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.

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

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.³With 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.”

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About Masimo

Masimo (NASDAQ: MASI) is a global medical technology company that develops and produces a wide array of industry-leading monitoring technologies, including innovative measurements, sensors, patient monitors, and automation and connectivity solutions. Our mission is to improve patient outcomes and reduce the cost of care. Masimo SET^® Measure-through Motion and Low Perfusion™ pulse oximetry, introduced in 1995, has been shown in over 100 independent and objective studies to outperform other pulse oximetry technologies.¹ Masimo SET^® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,⁴ improve CCHD screening in newborns,⁵and, when used for continuous monitoring with Masimo Patient SafetyNet™ in post-surgical wards, reduce rapid response team activations, ICU transfers, and costs.^6-9Masimo SET^® is estimated to be used on more than 200 million patients in leading hospitals and other healthcare settings around the world,² and is the primary pulse oximetry at 9 of the top 10 hospitals according to the 2020-21 U.S. News and World Report Best Hospitals Honor Roll.³ Masimo continues to refine SET^® and in 2018, announced that SpO₂ accuracy on RD SET^® sensors during conditions of motion has been significantly improved, providing clinicians with even greater confidence that the SpO₂ values they rely on accurately reflect a patient’s physiological status. In 2005, Masimo introduced rainbow^® Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb^®), oxygen content (SpOC™), carboxyhemoglobin (SpCO^®), methemoglobin (SpMet^®), Pleth Variability Index (PVi^®), RPVi™ (rainbow^® PVi), and Oxygen Reserve Index (ORi™). In 2013, Masimo introduced the Root^® Patient Monitoring and Connectivity Platform, built from the ground up to be as flexible and expandable as possible to facilitate the addition of other Masimo and third-party monitoring technologies; key Masimo additions include Next Generation SedLine^® Brain Function Monitoring, O3^® Regional Oximetry, and ISA™ Capnography with NomoLine^® sampling lines. Masimo’s family of continuous and spot-check monitoring Pulse CO-Oximeters^® includes devices designed for use in a variety of clinical and non-clinical scenarios, including tetherless, wearable technology, such as Radius-7^® and Radius PPG™, portable devices like Rad-67™, fingertip pulse oximeters like MightySat^® Rx, and devices available for use both in the hospital and at home, such as Rad-97^®. Masimo hospital automation and connectivity solutions are centered around the Masimo Hospital Automation™ platform, and include Iris Gateway^®, Patient SafetyNet, Replica™, Halo ION™, UniView™, UniView: 60™, and Masimo SafetyNet™. Additional information about Masimo and its products may be found at www.masimo.com. Published clinical studies on Masimo products can be found at www.masimo.com/evidence/featured-studies/feature/.

ORi and RPVi have not received FDA 510(k) clearance and are not available for sale in the United States. The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.

References

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.
Estimate: Masimo data on file.
http://health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview.
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.
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.
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.
Taenzer A et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
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.
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.

Forward-Looking Statements

This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, among others, statements regarding the potential effectiveness of Masimo Rad-G™, SET^®, and RRp^®. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our belief that Masimo's unique noninvasive measurement technologies, including Masimo Rad-G, SET^®, and RRp, contribute to positive clinical outcomes and patient safety; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions and unique advantages; risks related to COVID-19; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. We do not undertake any obligation to update, amend or clarify these statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.