NEUCHATEL, Switzerland--(BUSINESS WIRE)--Jun. 5, 2017--
Masimo (NASDAQ:MASI)
announced today, in conjunction with its CE marking, the limited market
release of the Spot-Check Rad-67™ Handheld Pulse CO-Oximeter®.
Rad-67 offers Measure-through Motion and Low Perfusion™ SET®
pulse oximetry and upgradeable rainbow® noninvasive
monitoring technology in a compact, portable spot-check device. With the
universal reusable rainbow® DCI®-mini sensor,
Rad-67 features Next Generation SpHb® (noninvasive total
hemoglobin) technology.
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Masimo Rad-67™ Handheld Pulse CO-Oximeter® with rainbow® DCI®-mini Sensor (Photo: Business Wire)
Next Generation SpHb technology offers improved motion tolerance and a
faster time to display SpHb results (in as few as 30 seconds). In
addition, field performance has been enhanced in lower hemoglobin
ranges. The rainbow® DCI-mini sensor allows patients of all
ages, from infants to adults, to be spot-checked using a reuseable
sensor. Next Generation SpHb, enabled when Rad-67 and the DCI-mini
sensor are used together, significantly advances the forefront of
noninvasive portable hemoglobin spot-checking.
Rad-67’s ability to provide portable spot-check measurements of both
oxygen saturation and SpHb, in addition to other noninvasive rainbow®
measurements, makes it a useful single-device solution in multiple care
areas and mobile environments, such as when screening patients during
blood donation drives, emergency room screening, and in physicians’
offices. In addition to a rechargeable battery with six-hour run time,
Rad-67 features a high-resolution, HD color display with intuitive
touchscreen navigation that automatically adjusts brightness to optimize
visibility in a variety of settings, including outdoors. The
slim-profile sensor connector port is designed to provide tactile
feedback upon proper connection. Multiple parameters are simultaneously
displayed, allowing for quick patient assessment.
Rad-67 provides convenient historical data review directly on the
device, with unique patient identifiers to help improve organization of
records and workflow. Using Bluetooth®, Rad-67 can connect
wirelessly to portable printers. Rad-67 also includes built-in wireless
connectivity via Wi-Fi. When used in conjunction with Masimo Iris
Gateway™ or Patient SafetyNet™*, data from Rad-67 can be sent directly
to the patient’s electronic medical record (EMR). Automating data
transfer with EMR integration may help reduce the possibility of human
error when manually transferring data.
Dr. Aryeh Shander, Chief of Anesthesiology, Critical Care Medicine at
Englewood Hospital and Medical Center, noted that “in the process of
screening for anemia, having the ability to detect hemoglobin
noninvasively is one of the greatest advances. Once low hemoglobin is
reported, confirmation with a conventional laboratory test will further
explore the possible causes.”
Joe Kiani, Founder and CEO of Masimo, said, “We’re proud to announce
Rad-67 with Next Generation SpHb technology. Next Generation SpHb
represents a significant enhancement to the noninvasive measurement we
invented a decade ago – a measurement we look forward to continuing to
improve.”
Rad-67 has not received 510(k) clearance and is not available for sale
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 by taking noninvasive monitoring to new sites
and applications. 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 including 16 of the top 20 hospitals listed in the
2016-17 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®),
and more recently, Pleth Variability Index (PVi®) and 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://www.masimo.com/cpub/clinical-evidence.htm.
*The use of the trademark Patient SafetyNet is under license from
University HealthSystem Consortium.
**Clinical decisions regarding red blood cell transfusions should be
based on the clinician’s judgment considering, among other factors:
patient condition, continuous SpHb monitoring, and laboratory diagnostic
tests using blood samples.
References
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1.
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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.
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2.
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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;338.
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3.
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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.
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4.
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Taenzer AH et al. Postoperative Monitoring – The Dartmouth
Experience. Anesthesia Patient Safety Foundation Newsletter.
Spring-Summer 2012.
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5.
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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.
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6.
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Estimate: Masimo data on file.
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7.
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http://health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview.
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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-67™ Pulse CO-Oximeter®. 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-67, contribute to
positive clinical outcomes and patient safety; 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: http://www.businesswire.com/news/home/20170605005349/en/
Source: Masimo
Masimo
Evan Lamb, 949-396-3376
elamb@masimo.com