Wearable, Wireless Sensor Provides Hassle-Free
Continuous Body Temperature Measurements
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.
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Masimo Radius Tº™ Continuous Thermometer
(Photo: Business Wire)
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
- 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.
- 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 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.
- Taenzer A et al. Postoperative Monitoring – The Dartmouth
Experience. Anesthesia Patient Safety Foundation Newsletter.
Spring-Summer 2012.
- 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.
- 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.
- Estimate: Masimo data on file.
-
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.
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Media Contact: Masimo Evan Lamb 949-396-3376
elamb@masimo.com
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