Rugged Handheld Device Provides Clinically
Proven Masimo SET® Pulse Oximetry and Respiration Rate
Monitoring
Masimo (NASDAQ: MASI) announced today FDA clearance of the
Rad-G™ Pulse Oximeter, a rugged handheld device that provides
clinically proven SET® pulse oximetry, respiration rate from the
pleth (RRp®), and other vital parameters for both spot-checking and
continuous monitoring. With its long-lasting rechargeable battery,
robust rubber casing, light weight, and a convenient new
direct-connect sensor capable of monitoring both adults and
children, Rad-G 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. Providing the ultimate in handheld versatility, Rad-G can
be used in a variety of settings, including but not limited to
physicians’ offices, outpatient services, long-term care
facilities, wellness clinics, first-response scenarios, and
limited-resource environments.
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Masimo Rad-G™ Pulse Oximeter (Photo:
Business Wire)
Launching alongside the device, the new multipurpose,
direct-connect Rad-G Sensor is indicated for monitoring both adult
and pediatric patients. By eliminating the need to stock and carry
multiple sensor types, the Rad-G Sensor further increases Rad-G’s
versatility and ease of use, especially in more challenging field
environments. In addition to this innovative new sensor, Rad-G is
compatible with the vast portfolio of Masimo reusable and
single-patient-use sensors, maximizing its flexibility and offering
clinicians the ability to customize the solution based on the
unique needs of each care setting.
First developed in partnership with The Bill & Melinda Gates
Foundation as a spot-check device for global use, the 2021 Rad-G
expands on its predecessor’s capabilities with the addition of
alarms and thus the ability to provide continuous monitoring –
without sacrificing any portability, convenience, or ruggedness.
Rad-G’s rechargeable battery provides an impressive 24 hours of use
between charges, allowing clinicians to work in outdoor, transport,
and emergency scenarios with confidence that Rad-G will continue to
function hour after hour. All the while, the high-resolution screen
displays a continuous pleth waveform and its fully configurable,
audible alarms help alert clinicians to changes in patient status
that may require their intervention.
In addition to Masimo SET® oxygen saturation (SpO2), pulse rate
(PR), perfusion index (Pi), and pleth variability index (PVi®),
Rad-G is also notable for its ability to use the same sensor to
monitor respiration rate from the plethysmograph, with RRp. With
breathing difficulty generally considered one of the earliest signs
of patient deterioration, Masimo hopes that the availability of RRp
on Rad-G may play a role in assisting clinicians and public health
officials as they seek to combat respiratory-related illnesses,
including pneumonia and COVID-19.
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.1 SET® is
estimated to be used on more than 200 million patients a year2 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.3 With
Masimo SET® technology in Rad-G, clinicians have access to
hospital-grade, accurate pulse oximetry measurements in the palm of
their hands.
Joe Kiani, Founder and CEO of Masimo, said, “With the Rad-G
Pulse Oximeter, we set out to create an accessible, high-quality
care solution that clinicians can rely on in a multitude of care
settings. We are bringing our expertise in pulse oximetry to a
smaller, more lightweight, rugged, and versatile handheld device –
without sacrificing any of the advantages that help provide
clinicians with critical insights into patient status. As the
COVID-19 pandemic continues, it’s more imperative than ever that
caregivers have access to the most accurate and reliable pulse
oximetry monitoring technologies. We are proud to offer Rad-G among
our suite of solutions powered by the breakthrough technology, SET®
pulse oximetry.”
@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,4 improve CCHD screening in newborns,5 and, when used for
continuous monitoring with Masimo Patient SafetyNet™ in
post-surgical wards, reduce rapid response team activations, ICU
transfers, and costs.6-9 Masimo SET® is estimated to be used on
more than 200 million patients in leading hospitals and other
healthcare settings around the world,2 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.3 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.
- Estimate: Masimo data on file.
-
http://health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview.
- 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 AH 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 SP 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 Masimo Rad-G™, SET®, and
RRp®. 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®, and RRp, 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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