Masimo (NASDAQ: MASI) today announced the CE marking of the
Rad-G™ with Temperature, a rugged handheld device that provides
clinically proven SET® pulse oximetry, respiration rate from the
pleth (RRp®), and other important parameters alongside
clinical-grade, non-contact infrared thermometry. With its
long-lasting rechargeable battery, robust rubber casing, light
weight, and integrated noninvasive, real-time forehead temperature
measurement, Rad-G with Temperature 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. Coupled with the universal
Mini-Clip™ pulse oximeter sensor to provide the ultimate in
handheld versatility, Rad-G with Temperature can be used in a
variety of settings, including but not limited to entry screening,
physicians’ offices, outpatient services, long-term care
facilities, wellness clinics, first-response scenarios, and
limited-resource environments both indoors and in the field. Rad-G
can provide both spot-check measurement and continuous
monitoring.
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Masimo Rad-G™ with Temperature (Photo:
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The infrared thermometry offered by Rad-G with Temperature
provides a host of benefits. Rad-G’s thermometer is non-contact and
does not require probe covers or other disposable accessories. Its
integration into the Rad-G platform eliminates the need for
clinicians to locate a separate clinical thermometer to take body
temperature measurements and ensures that many people can be
seamlessly and efficiently screened for temperature, with one-touch
operation, alongside oxygen saturation, respiration rate, and more,
in the same session, using a single device. Designed from the start
to maximize portability and battery life, Rad-G’s rechargeable
battery provides an impressive 24 hours of continuous use between
charges – allowing clinicians to work in transport, emergency, and
other challenging scenarios with confidence that the device will
continue to function hour after hour.
First developed in partnership with The Bill & Melinda Gates
Foundation as a spot-check device for use in pneumonia screening,
the Rad-G with Temperature expands on its predecessor’s
capabilities not only with the ability to measure temperature, but
the addition of alarms, and thus the ability to provide both
continuous monitoring and spot-check measurement – without
sacrificing any portability, convenience, or ruggedness. Using the
included power adapter, Rad-G can be easily converted from a
handheld, spot-check device into a continuous monitoring device, in
the absence of other multi-parameter monitors. As of 2010 – twenty
years after use of pulse oximetry during surgery became routine in
affluent countries – more than 77,000 operating theaters in low-
and middle-income countries were still conducting surgery without
pulse oximetry.1 Working with a myriad of non-profit organizations,
Rad-G is being made available at an affordable price so that the
five billion people who don’t have access to reliable pulse
oximetry can finally have it. When used for continuous monitoring,
the high-resolution screen displays a continuous pleth waveform and
the fully configurable, audible alarms help alert clinicians to
changes in patient status that may require their intervention.
The development of Rad-G stems in part from the findings of a
multi-center, prospective, two-stage observation study funded by
The Bill & Melinda Gates Foundation, whose protocols were
published in JMIR Research Protocols, in which Dr. Kevin Baker, MA,
MSc, Senior Research Specialist at the Malaria Consortium, and
colleagues sought to identify the most accurate, usable, and
acceptable devices to aid community health workers in the diagnosis
of pneumonia symptoms in resource-poor settings.2 The researchers
found that “The Masimo mobile phone pulse oximeter [iSpO2® Rx] had
the best overall performance across all measures and in both age
strata of the children the device was tested on. This may be due to
the motion signal processing techniques incorporated in Masimo
pulse oximeters which attempts to reduce motion artefact, which may
be particularly important when using these devices on moving
children.”3
Paul Farmer, Kolokotrones University Professor at Harvard, Chair
of the Department of Global Health and Social Medicine at Harvard
Medical School, Chief of the Division of Global Health Equity at
Brigham and Women’s Hospital in Boston, and Co-Founder and Chief
Strategist of Partners in Health, said, “In the places where I’ve
worked around the world, there has always been a demand for tools
that enable the continuous monitoring of key vital signs, like
respiration rate, oxygen saturation, and temperature, which can
help providers and patients fight against illnesses from pneumonia
to congenital heart disease.”
Eric D. McCollum, MD, MPH, Director of the Global Program in
Respiratory Sciences at the Johns Hopkins School of Medicine in
Baltimore, Maryland, said, “The Masimo Rad-G is a fantastic device
that is thoughtfully crafted and user-friendly for both healthcare
workers with diverse training backgrounds and pediatric patients
across the age spectrum. We are using the Rad-G currently in four
countries in our pediatric global health work and the device is no
doubt at the high standards set by Masimo with its range of
high-quality pulse oximeters. The healthcare providers and children
love it.”
“Bacterial and viral pneumonias – including those caused by
COVID-19 – are a leading cause of death in children and adults
globally, with a disproportionate burden of disease in low-resource
settings,” said Peter Moschovis, MD, MPH, a pulmonologist at
Massachusetts General Hospital. “Pulse oximetry plays an important
role in the triage and management of patients with pneumonia.”
Joe Kiani, Founder and CEO of Masimo, said, “With Rad-G, we set
out to create an accessible, high-quality care solution that
clinicians can rely on in a multitude of care settings to serve the
five billion people on our planet that to date have not had access
to pulse oximetry, let alone SET® pulse oximetry. With the addition
of temperature measurement, Rad-G is more versatile than ever,
streamlining the assessment of multiple key vital signs. Many
caregivers travel miles, sometimes on bike, sometimes on foot, to
help patients, so having a product that is light, small,
multifunctional, and ‘accurate when you need it most’ is crucial.
Rad-G was designed to be just that.”
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.4 SET® is
estimated to be used on more than 200 million patients a year5 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.6 With
Masimo SET® technology in Rad-G, clinicians have access to accurate
pulse oximetry measurements in the palm of the hand.
In a new cross-sectional study published in Acta Paediatrica,
Dr. Baker and colleagues assessed the utility of Rad-G by observing
how it was used by healthcare workers screening children under five
for pneumonia in three regions of Ethiopia in 2018.7 The
researchers found that healthcare workers gave correct treatment
and referral guidance using Rad-G’s results and their assessment of
other symptoms in 94.9% and 95.8% of cases in the first and second
of their two observation groups, respectively.
In addition to temperature measurements and Masimo SET® oxygen
saturation (SpO2), pulse rate (PR), perfusion index (Pi), and PVi®
(for assessing fluid responsiveness), the same SpO2 sensor can be
used to monitor respiration rate from the plethysmograph, with RRp.
Difficulty breathing and fever are generally considered two of the
earliest signs of patient deterioration, and Masimo hopes that the
availability of RRp and thermometry on Rad-G may play a role in
assisting clinicians and public health officials as they seek to
combat numerous types of illnesses, including pneumonia and
COVID-19.
Rad-G with Temperature can be used with a variety of reusable
and single-patient use sensors. The universal direct-connect Rad-G
reusable sensor, indicated for monitoring adult, pediatric, and
infant patients, helps to eliminate the need to stock and carry
multiple sensor types, increasing the device’s versatility and ease
of use, especially in more challenging field environments. Rad-G
with Temperature is also compatible with the vast portfolio of
Masimo single-patient-use adhesive sensors—including Masimo RD SET®
sensors, which offer best-in-class accuracy specifications of 1.5%
in conditions of motion and no motion—ensuring clinicians can
customize their setup based on the unique needs of each care
setting. In addition, Rad-G is designed to work reliably on all
people, from white to black, neonate to geriatric.
Rad-G is FDA 510(k) cleared and is available in the U.S. Rad-G
with Temperature has not received FDA 510(k) clearance and is not
currently available in the U.S. PVi is FDA 510(k) cleared as an
indicator of fluid responsiveness in select populations of
mechanically ventilated adult patients in the U.S.
@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.4 Masimo SET® has also been shown to
help clinicians reduce severe retinopathy of prematurity in
neonates,8 improve CCHD screening in newborns,9 and, when used for
continuous monitoring with Masimo Patient SafetyNet™ in
post-surgical wards, reduce rapid response team activations, ICU
transfers, and costs.10-13 Masimo SET® is estimated to be used on
more than 200 million patients in leading hospitals and other
healthcare settings around the world,5 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.6 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
-
https://www.theatlantic.com/health/archive/2017/02/pulse-oximeter/516510/
- Baker K, Akasiima M, Wharton-Smith A, Habte T, Matata L,
Nanyumba N, Okwir M, Sebsibe A, Marasciulo M, Petzold M, Källander
K. “Performance, Acceptability, and Usability of Respiratory Rate
Timers and Pulse Oximeters When Used by Frontline Health Workers to
Detect Symptoms of Pneumonia in Sub-Saharan Africa and Southeast
Asia: Protocol for a Two-Phase Multisite, Mixed-Methods Trial.”
JMIR Res Protoc. 2018;7(10):e10191) doi: 10.2196/10191.
-
https://openarchive.ki.se/xmlui/bitstream/handle/10616/46833/Thesis_Kevin_Baker.pdf?sequence=4&isAllowed=y
- 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.
- Baker K, Ward C, Maurel A, de Cola M, Smith H, Getachew D,
Habte T, McWhorter C, LaBarre P, Karlstrom J, Ameha A, Tariku A,
Black J, Bassat Q, Kallander K. “Usability and acceptability of a
multimodal respiratory rate and pulse oximeter device in case
management of children with symptoms of pneumonia: A
cross-sectional study in Ethiopia.” Acta Paediatrica. 19 Nov 2020.
DOI: 10.1111/apa.15682
- 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.
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 Rad-G™,
SET®, RRp®, and iSpO2® Rx. 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®, RRp, and iSpO2 Rx,
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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