Masimo Announces Consumer Launch of the Radius Tº™ Continuous Thermometer, a More Convenient Way to Keep Track of Fever

Rhea-AI Summary

Masimo (NASDAQ: MASI) has launched the Radius Tº™ Continuous Thermometer, a wearable device that continuously monitors body temperature and sends data to a smartphone app. This innovation aims to enhance patient care by providing real-time temperature trends without interrupting daily activities, such as sleep. The Radius Tº sensor offers laboratory-accurate measurements within ±0.1ºC and is designed for use in various age groups. While not FDA 510(k) cleared, it is CE marked and marketed under the FDA’s COVID-19 enforcement policy.

Positive

• Launch of Radius Tº Continuous Thermometer, enhancing patient care monitoring.
• Device provides continuous body temperature data without interruption, aiding in timely responses to health changes.
• Temperature measurements estimated with laboratory accuracy of ±0.1ºC, surpassing typical oral thermometry.
• Flexible design allows comfortable wear for up to 8 days.

Negative

• Radius Tº is not FDA 510(k) cleared, limiting its marketing scope.
• Device marketed under FDA's COVID-19 enforcement policy, indicating temporary regulatory approval.

IRVINE, Calif.--(BUSINESS WIRE)--Masimo (NASDAQ: MASI) today announced the launch of the Radius Tº™ Continuous Thermometer for consumers. Unlike spot-check, episodic thermometers, the wearable, wireless Radius Tº measures body temperature continuously, seamlessly transmitting data and customizable temperature notifications to the user’s smartphone – helping caregivers, such as parents, monitor loved ones’ temperatures even while they sleep.

Radius Tº represents a paradigm shift in thermometry by making it continuous, wearable, and hassle-free. Traditional periodic and invasive methods depend on the user repeatedly conducting a series of steps that can interrupt daily activities, including sleep, and can miss body temperature trends and patterns. With a traditional thermometer, a person may only notice a spike in temperature hours after a spike has occurred, or may not even become aware of it if it is during sleep. By contrast, Radius Tº continuously and seamlessly measures temperatures using a small, inconspicuous, wearable sensor that can be easily applied to anyone from children to elderly adults – with no action needed after initial application to the skin. Radius Tº eliminates manual measurements while providing continuous insight into changes in the user’s temperature and helps users understand which way their temperature is trending. In addition, Radius Tº uses proprietary algorithms to provide body temperature measurements for users five years or older that approximate oral temperature, not just external skin temperature. Radius Tº provides temperature measurements with laboratory accuracy within ±0.1ºC, whereas other oral thermometry solutions typically have laboratory accuracy within ±0.2ºC.

Earlier this year, Masimo launched Radius Tº as part of the Masimo SafetyNet™ remote patient management solution, for use both in hospitals and by patients at home. Dr. Neal Fleming, M.D., Ph.D., Vice Chair for Education in the Department of Anesthesiology and Pain Medicine at UC Davis Health, commenting on his experience using Radius Tº, said, “Radius Tº is noninvasive and convenient for patients. I do not have to interrupt their daily activities or their sleep and it provides me continuous trend data that is a powerful guide to patient care. It makes it easier for me to recognize possible changes in their symptoms.”

Flexible and slim, each disposable Radius Tº sensor can be worn comfortably for up to eight days, and is water resistant during shower and exercise. Users are free to carry on with their daily activities and sleep, without interruption or hassle – all while Radius Tº continuously collects temperature data. Using built-in Bluetooth^®, the sensor easily pairs with the Masimo Radius Tº App on the user’s smartphone, providing real-time temperature values with user-definable automatic notifications (for example, when temperature exceeds a certain user-selected threshold or if it spikes), as well as detailed historical trending data, revealing the baseline and fluctuation patterns unique to each person that can help users determine whether a rise in temperature warrants action. In addition, the user-friendly Masimo Radius Tº App can support multiple family member profiles and can be easily set to schedule medication reminders.

Joe Kiani, Founder and CEO of Masimo, said, “We’re excited to expand our growing line of consumer solutions, which includes MightySat^® and Masimo Sleep™, with the Radius Tº Continuous Thermometer. For years, clinicians have trusted Masimo technology to monitor patients in the hospital. With Radius Tº and our other consumer solutions, we’re bringing our expertise and experience in accurately and reliably measuring physiological data from the hospital to the home.”

Radius Tº is not FDA 510(k) cleared. The device is marketed under the FDA’s Enforcement Policy for Clinical Electronic Thermometers During COVID-19. Radius Tº is CE marked.

@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.¹ Masimo SET^® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,² improve CCHD screening in newborns,³ and, when used for continuous monitoring with Masimo Patient SafetyNet™ in post-surgical wards, reduce rapid response team activations, ICU transfers, and costs.^4-7 Masimo SET^® is estimated to be used on more than 200 million patients in leading hospitals and other healthcare settings around the world,⁸ 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.⁹ 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

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. 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.
3. 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.
4. 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.
5. Taenzer A et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
6. 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.
7. 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.
8. Estimate: Masimo data on file.
9. 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 Tº™. 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 Radius Tº, 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.