Radius PCG with Bluetooth® Connectivity
Seamlessly Integrates Tetherless Mainstream Capnography with
Root
Masimo (NASDAQ: MASI) announced today that Radius PCG™, a
portable real-time capnograph with wireless Bluetooth®
connectivity, has received FDA 510(k) clearance. Radius PCG
connects with the Root® Patient Monitoring and Connectivity
Platform to provide seamless, tetherless mainstream capnography for
patients of all ages. Radius PCG joins the growing family of
tetherless Masimo technologies that includes Radius PPG™, which
offers Masimo SET® Measure-through Motion and Low Perfusion pulse
oximetry, and Radius Tº™, which provides continuous temperature
measurements. Radius PCG requires no routine calibration, with
accurate end-tidal carbon dioxide (EtCO2) and respiration rate
measurements and continuous EtCO2 waveforms displayed within 15
seconds—all in a small, portable package that can fit in the palm
of a hand.
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Masimo Root® with Radius PCG™ (Photo:
Business Wire)
“Radius PCG has been a game changer for our clinical team,”
commented Joseph DiMartino, MSN RN, NE-BC, CCRN-K, Associate Vice
President of Nursing at Temple University Hospital in Philadelphia.
“It provides us with a portable and rapid measure of capnography
for confirming airway placement in accordance with AHA
guidelines.”
Wirelessly connected to Root, Radius PCG presents a compelling
mainstream capnography solution, offering:
- Cable-free Capnography: High-quality capnography without a
tethered connection to Root reduces the possibility of an
interruption in capnography monitoring by minimizing tugging on the
breathing circuit. In busy operating rooms, where space is already
at a premium, and where capnography cables can easily be pulled and
dropped on the floor—potentially damaging the fragile and expensive
capnography sensor head—the reduction in clutter may be especially
welcome.
- Automated Documentation: Root, in conjunction with the Masimo
Hospital Automation™ Platform, automates electronic charting of
patient data, including the data collected by Radius PCG, in
hospital electronic medical record (EMR) systems, to simplify and
speed workflows, as well as reduce the likelihood of transcription
errors.1
- Maximized Data Visibility and Manipulation: Root’s large,
multi-touch, high-resolution screen provides an easily
interpretable secondary display of large, crisp EtCO2 waveforms,
improving visibility and assisting clinicians in identifying wave
patterns suggestive of airway obstruction or tube dislodgement.
Clearly displayed trend data for up to 96 hours helps clinicians
review patient progress over time, helping guide ventilation
efforts. And the intuitive touch-screen interface allows clinicians
to quickly adjust the trend display range and configure alarm
settings to meet the needs of each patient.
- Hassle-free Connectivity: Radius PCG quickly and effortlessly
pairs with Root via Bluetooth, supporting seamless integration into
clinical workflows while providing the benefits of reliable
capnography.
Tom Friedland, MD, Emergency Medicine Physician, described
Radius PCG as “the easiest and most affordable solution to switch
your hospital from the unreliable color change CO2 detector to
waveform capnography. #NoTraceWrongPlace.”
“Radius PCG is indispensable for emergencies, as well as for
monitoring the COVID patients in our house,” added Kai Schurig,
Head of the Biomedical Department at Marien Hospital in Hamburg,
Germany. “These handheld devices are very reliable and fail very
rarely. The users are very satisfied and treat the device
accordingly.”
Root is a powerful, expandable hub that integrates an array of
technologies, devices, and systems to provide multimodal monitoring
and connectivity solutions. Root’s plug-and-play expansion
capabilities allow clinicians to simultaneously monitor with Radius
PCG and many other measurements, such as Masimo SET®, advanced
rainbow® Pulse CO-Oximetry measurements, O3® regional oximetry, and
SedLine® brain function monitoring, for expanded visibility of
patient status. Using Root in combination with the Hospital
Automation Platform, monitoring data from all connected devices can
be automatically charted in EMRs.
Joe Kiani, Founder and CEO of Masimo, said, “With its wireless
connectivity, Radius PCG is a powerful and useful tool for
assessing end-tidal CO2 in a multitude of clinical scenarios.
Masimo continues to make clinically relevant, accurate patient data
available, helping clinicians gain the insights they need to make
the best decisions and improve patient outcomes.”
@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.2 Masimo SET® has also been shown to
help clinicians reduce severe retinopathy of prematurity in
neonates,3 improve CCHD screening in newborns,4 and, when used for
continuous monitoring with Masimo Patient SafetyNet™ in
post-surgical wards, reduce rapid response team activations, ICU
transfers, and costs.5-8 Masimo SET® is estimated to be used on
more than 200 million patients in leading hospitals and other
healthcare settings around the world,9 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.10 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
- The Value of Medical Device Interoperability. West Health
Institute. 1013.
- 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 Root® with Radius
PCG™. 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 Root with Radius PCG, 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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