Continuous Oxygenation and Ventilation Monitoring with Upgradeable
rainbow® Parameters in a Compact, Standalone
Device
IRVINE, Calif.--(BUSINESS WIRE)--Apr. 10, 2018--
Masimo (NASDAQ:
MASI) announced today the CE marking of the Rad-97™ Pulse CO-Oximeter®
with integrated NomoLine™ capnography. With this clearance, Rad-97 is
now available both within and outside the United States in three
configurations: Rad-97, Rad-97 with integrated noninvasive blood
pressure, and now Rad-97 with NomoLine capnography. Rad-97 offers Masimo
noninvasive and continuous monitoring, through Measure-through Motion
and Low Perfusion™ SET® pulse oximetry, upgradeable rainbow®
technology, and NomoLine capnography in a compact, standalone monitor
that incorporates advanced customizability, connectivity, and device
integration capabilities.
This press release features multimedia. View the full release here:
https://www.businesswire.com/news/home/20180410005671/en/
Masimo Rad-97™ Pulse CO-Oximeter® with NomoLine™ Capnography (Photo: Business Wire)
Rad-97 with NomoLine capnography features an integrated ISA™ CO2
module with NomoLine sampling lines for sidestream capnography, with an
adapter for intubated patients – meeting continuous monitoring and
capnography needs in a single device. Rad-97 with capnography displays
continuous end-tidal carbon dioxide (EtCO2) values with
numeric, trend, and waveform viewing options, as well as fractional
concentration of inspired carbon dioxide (FiCO2) and
respiration rate. With both integrated capnography and Masimo acoustic
respiration rate (RRa®) available on a single device,
clinicians have the flexibility of choosing the most appropriate
respiration monitoring method for each patient.
Rad-97 combines its portable, compact form factor with a
high-resolution, multi-touch color display that allows clinicians to
easily customize the device for each monitoring use case – bringing
rainbow SET™ measurements and capnography measurements to care areas
where a small footprint or high portability is desired. Rad-97 features
built-in enterprise WiFi capability, allowing it to connect wirelessly
to supplemental patient monitoring systems including Masimo Patient
SafetyNet™*, facilitating automatic data transfer to hospital electronic
medical record (EMR) systems. The easy-to-use, intuitive interface helps
to simplify charting workflows for vital sign monitoring and patient
data capture.
“We’re delighted to bring the full family of Rad-97 products to markets
outside the United States,” said Joe Kiani, Founder and CEO of Masimo.
“We believe Rad-97, with its versatility and customizability, will play
an especially important role in helping hospitals improve their
monitoring capabilities with convenient, easy-to-use device and
technology solutions – ultimately helping to improve patient care and
safety.”
Rad-97, Rad-97 with noninvasive blood pressure, and Rad-97 with NomoLine
capnography have received FDA 510(k) clearance and are also available in
the United States.
@MasimoInnovates |
#Masimo
*The use of the trademark Patient SafetyNet is under license from
University HealthSystem Consortium.
About Masimo
Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive
monitoring technologies. Our mission is to improve patient outcomes and
reduce the cost of care. In 1995, the company debuted Masimo SET®
Measure-through Motion and Low Perfusion™ pulse oximetry, which has been
shown in multiple studies to significantly reduce false alarms and
accurately monitor for true alarms. Masimo SET® has also been
shown to help clinicians reduce severe retinopathy of prematurity in
neonates,1 improve CCHD screening in newborns,2
and, when used for continuous monitoring with Masimo Patient SafetyNet™*
in post-surgical wards, reduce rapid response activations and costs.3,4,5
Masimo SET® is estimated to be used on more than 100 million
patients in leading hospitals and other healthcare settings around the
world,6 and is the primary pulse oximetry at 17 of the top 20
hospitals listed in the 2017-18 U.S. News and World Report Best
Hospitals Honor Roll.7 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®), and more
recently, Oxygen Reserve Index™ (ORi™), in addition to SpO2,
pulse rate, and perfusion index (Pi). In 2014, Masimo introduced Root®,
an intuitive patient monitoring and connectivity platform with the
Masimo Open Connect® (MOC-9®) interface, enabling
other companies to augment Root with new features and measurement
capabilities. Masimo is also taking an active leadership role in mHealth
with products such as the Radius-7® wearable patient monitor,
iSpO2® pulse oximeter for smartphones, and the
MightySat™ fingertip pulse oximeter. Additional information about Masimo
and its products may be found at www.masimo.com.
Published clinical studies on Masimo products can be found at http://www2.masimo.com/evidence/featured-studies/feature/.
ORi has not received FDA 510(k) clearance and is not available for sale
in the United States.
*The use of the trademark Patient SafetyNet is under license from
University HealthSystem Consortium.
References
1. 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.
2.
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.
3. 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.
4.
Taenzer AH et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia
Patient Safety Foundation Newsletter. Spring-Summer 2012.
5.
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.
6.
Estimate: Masimo data on file.
7. 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 Rad-97™ and NomoLine™. 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-97 and NomoLine, 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; 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20180410005671/en/
Source: Masimo
Masimo
Evan Lamb, 949-396-3376
elamb@masimo.com