The Radius Tº™ Wearable Temperature Sensor
Automates Remote Monitoring of Patient Temperature Status
Masimo (NASDAQ: MASI) today announced a significant expansion to
the Masimo SafetyNet™ platform with the introduction of Radius Tº™,
a wearable, wireless sensor that provides continuous body
temperature measurements. By augmenting the already powerful Masimo
SafetyNet, which features Radius PPG™ tetherless pulse oximetry,
with Radius Tº, the remote patient management solution becomes
capable of tracking four key vital signs – oxygen saturation,
respiration rate, pulse rate, and now temperature – making it an
ideal solution for assessing the status of patients with suspected
or low-acuity COVID-19, among many other remote patient management
uses. Unlike spot-check thermometry solutions, Radius Tº measures
body temperature continuously, providing remote notifications when
a patient’s temperature is outside a clinician-specified range –
giving peace of mind to caregiver and patient alike.
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Masimo SafetyNet™ with Radius PPG™ and
Radius Tº™ (Photo: Business Wire)
Masimo SafetyNet uses a tetherless, wearable single-patient-use
Masimo SET® Measure-through Motion and Low Perfusion™ pulse
oximetry sensor to monitor a patient’s blood oxygen saturation and
pulse rate, as well as respiration rate, perfusion index, and PVi®.
Masimo SafetyNet is designed to help manage the surge in COVID-19
patients while maintaining distance from other patients and
providers, allowing hospitals to expand remote patient monitoring
into alternative care spaces, including overflow locations,
emergency recovery facilities, and home care settings. The
telehealth platform combines tetherless pulse oximetry—and now also
Radius Tº continuous temperature measurement – with a cloud-based
remote data capture and surveillance platform accessible from a
patient’s Android or iOS smartphone or smart device. Monitoring key
physiological data provides clinicians with the ability to assess
patient status and facilitates awareness of the need for
intervention.
Temperature measurement by patients at home typically occurs
intermittently, at the prompting of a clinician, and is prone to
poor compliance in the collection and reporting of data to
healthcare providers in a timely, consistent fashion. A patient
taking their temperature at regular or semi-regular intervals may
only notice a spike in temperature hours after a fever has begun,
or may not even be aware of it, delaying possible clinical
intervention. In contrast, Radius Tº collects data continuously and
seamlessly, recording trend data and automatically notifying
remotely when a clinician-specified high temperature threshold is
breached, without any action needed on the patient’s part. By
eliminating inconsistent manual measurements and concerns about
patient compliance, while providing continuous insight into changes
in body temperature, Radius Tº is intended to significantly improve
patient status assessment workflows.
Radius Tº is small, light, and comfortable, and is easily
applied to the chest. Each shower-proof, single-patient-use sensor
lasts up to 8 days and can be worn throughout the day and night,
allowing patients to continue normal daily activities while still
being monitored. Applied to the skin, Radius Tº uses proprietary
algorithms to measure the patient’s body temperature, not just
external skin temperature, with laboratory accuracy within ±0.1ºC,
whereas other thermometry solutions typically have laboratory
accuracy within ±0.2ºC. Using Bluetooth®, Radius Tº provides this
continuous data to the Masimo SafetyNet app on the patient’s
smartphone and via secure cloud to clinicians back at the hospital,
allowing them to track and trend a patient’s body temperature,
helping them to spot potential deterioration in patient status
using the web-based Masimo SafetyNet Clinician Portal.
Joe Kiani, Founder and CEO of Masimo, said, “We’re proud to add
this noninvasive, continuous, wearable thermometer solution to our
growing family of remote patient management solutions. Masimo
SafetyNet has already helped clinicians effectively care for
countless patients during the pandemic. With the addition of Radius
Tº, Masimo SafetyNet becomes an even more useful tool for remotely
managing patients with COVID-19 and many other health
concerns.”
Radius Tº is indicated for use on patients 5 years and older.
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.
@MasimoInnovates | #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 2019-20 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 Masimo SafetyNet™ and
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 Masimo SafetyNet and 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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Masimo Evan Lamb 949-396-3376 elamb@masimo.com
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