Masimo Announces FDA Clearance of Radius PCG™ for the Root® Patient Monitoring and Connectivity Platform

Radius PCG with Bluetooth^® Connectivity Seamlessly Integrates Tetherless Mainstream Capnography with Root

IRVINE, Calif.–(BUSINESS WIRE)–Masimo (NASDAQ: MASI) announced today that Radius PCG™, a portable real-time capnograph with wireless Bluetooth^® connectivity, has received FDA 510(k) clearance. Radius PCG connects with the Root^® Patient Monitoring and Connectivity Platform to provide seamless, tetherless mainstream capnography for patients of all ages. Radius PCG joins the growing family of tetherless Masimo technologies that includes Radius PPG™, which offers Masimo SET^® Measure-through Motion and Low Perfusion pulse oximetry, and Radius Tº™, which provides continuous temperature measurements. Radius PCG requires no routine calibration, with accurate end-tidal carbon dioxide (EtCO₂) and respiration rate measurements and continuous EtCO₂ waveforms displayed within 15 seconds—all in a small, portable package that can fit in the palm of a hand.

“Radius PCG has been a game changer for our clinical team,” commented Joseph DiMartino, MSN RN, NE-BC, CCRN-K, Associate Vice President of Nursing at Temple University Hospital in Philadelphia. “It provides us with a portable and rapid measure of capnography for confirming airway placement in accordance with AHA guidelines.”

Wirelessly connected to Root, Radius PCG presents a compelling mainstream capnography solution, offering:

• Cable-free Capnography: High-quality capnography without a tethered connection to Root reduces the possibility of an interruption in capnography monitoring by minimizing tugging on the breathing circuit. In busy operating rooms, where space is already at a premium, and where capnography cables can easily be pulled and dropped on the floor—potentially damaging the fragile and expensive capnography sensor head—the reduction in clutter may be especially welcome.
• Automated Documentation: Root, in conjunction with the Masimo Hospital Automation™ Platform, automates electronic charting of patient data, including the data collected by Radius PCG, in hospital electronic medical record (EMR) systems, to simplify and speed workflows, as well as reduce the likelihood of transcription errors.¹
• Maximized Data Visibility and Manipulation: Root’s large, multi-touch, high-resolution screen provides an easily interpretable secondary display of large, crisp EtCO₂ waveforms, improving visibility and assisting clinicians in identifying wave patterns suggestive of airway obstruction or tube dislodgement. Clearly displayed trend data for up to 96 hours helps clinicians review patient progress over time, helping guide ventilation efforts. And the intuitive touch-screen interface allows clinicians to quickly adjust the trend display range and configure alarm settings to meet the needs of each patient.
• Hassle-free Connectivity: Radius PCG quickly and effortlessly pairs with Root via Bluetooth, supporting seamless integration into clinical workflows while providing the benefits of reliable capnography.

Tom Friedland, MD, Emergency Medicine Physician, described Radius PCG as “the easiest and most affordable solution to switch your hospital from the unreliable color change CO₂ detector to waveform capnography. #NoTraceWrongPlace.”

“Radius PCG is indispensable for emergencies, as well as for monitoring the COVID patients in our house,” added Kai Schurig, Head of the Biomedical Department at Marien Hospital in Hamburg, Germany. “These handheld devices are very reliable and fail very rarely. The users are very satisfied and treat the device accordingly.”

Root is a powerful, expandable hub that integrates an array of technologies, devices, and systems to provide multimodal monitoring and connectivity solutions. Root’s plug-and-play expansion capabilities allow clinicians to simultaneously monitor with Radius PCG and many other measurements, such as Masimo SET^®, advanced rainbow^® Pulse CO-Oximetry measurements, O3^® regional oximetry, and SedLine^® brain function monitoring, for expanded visibility of patient status. Using Root in combination with the Hospital Automation Platform, monitoring data from all connected devices can be automatically charted in EMRs.

Joe Kiani, Founder and CEO of Masimo, said, “With its wireless connectivity, Radius PCG is a powerful and useful tool for assessing end-tidal CO₂ in a multitude of clinical scenarios. Masimo continues to make clinically relevant, accurate patient data available, helping clinicians gain the insights they need to make the best decisions and improve patient outcomes.”

@Masimo | #Masimo

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.² Masimo SET^® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,³ improve CCHD screening in newborns,⁴ and, when used for continuous monitoring with Masimo Patient SafetyNet™ in post-surgical wards, reduce rapid response team activations, ICU transfers, and costs.^5-8 Masimo SET^® is estimated to be used on more than 200 million patients in leading hospitals and other healthcare settings around the world,⁹ 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.¹⁰ 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, iSirona™, 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

1. The Value of Medical Device Interoperability. West Health Institute. 1013.
2. 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.
3. 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.
4. 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.
5. Taenzer A 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.
6. Taenzer A et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
7. McGrath S 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.
8. 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.
9. Estimate: Masimo data on file.
10. http://health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview.

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 Radius Root^® with Radius PCG™. 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 Root with Radius PCG, 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.

Contacts

Masimo
Evan Lamb

949-396-3376

elamb@masimo.com