IRVINE, Calif.--(BUSINESS WIRE)--Sep. 18, 2017--
Masimo (NASDAQ:MASI)
announced today FDA 510(k) clearance and full market release of Rad-97™
Pulse CO-Oximeter®,including configurations with
integrated NomoLine™ capnography and noninvasive blood pressure (NIBP)
measurement from SunTech Medical. Rad-97 offers Masimo noninvasive and
continuous monitoring, through Measure-through Motion and Low Perfusion™
SET® pulse oximetry and upgradeable rainbow®
technologies, in a compact, standalone monitor that incorporates
advanced customizability, connectivity, and device integration
capabilities.
This Smart News Release features multimedia. View the full release here:
http://www.businesswire.com/news/home/20170918005327/en/
Masimo Rad-97™ Pulse CO-Oximeter® (center), Rad-97 with Integrated Noninvasive Blood Pressure (left), and Rad-97 with Integrated NomoLine™ Capnography (right) (Photo: Business Wire)
“We’re excited to bring the easy-to-use, compact Rad-97 to the US,” said
Joe Kiani, Founder and CEO of Masimo. “Rad-97 brings together our core
SET® and rainbow® technologies with advanced,
workflow-enhancing connectivity solutions. We believe it will be an
indispensable addition to many healthcare environments, including
lower-acuity settings in hospitals, alternate care, and telehealth.”
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 to care areas where a small footprint or high
portability is desired. Users can also rapidly configure the device to
accommodate different patient populations using customizable profiles. A
rechargeable battery lasting approximately four hours allows Rad-97 to
be used in situations where extended operation without access to AC
power is needed. An optional roll stand allows for tetherless device
transport, offering additional flexibility in situations where space is
limited.
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. Rad-97 is also compatible with
existing nurse call systems. Data from extended monitoring sessions,
such as sleep studies, can be rapidly downloaded via USB, Ethernet, or
WiFi.
Rad-97 also supports point-to-point Bluetooth® wireless
connections with compatible devices, such as thermometers, glucometers,
and weight scales, allowing patient data to be seamlessly transferred to
Rad-97 and connected upstream systems. Rad-97 will also be available
with an optional camera that will provide a high-resolution video feed,
as well as audio, to the Patient SafetyNet view-station. The
camera-equipped Rad-97 will allow patients and clinicians to communicate
remotely with compatible Patient SafetyNet software, making it
well-suited as a point-of-care device for telehealth.
Rad-97 with 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) monitoring with
numeric, trend, and waveform viewing options, as well as fractional
concentration of inspired carbon dioxide (FiCO2) and
respiration rate. NomoLine capnography reduces delays in respiration
rate measurement in both low and high ranges, accurately measures
respiration rate, and reduces the incidence of filter line occlusions,
as a result of NomoLine moisture wicking technology.
With Rad-97 NIBP, oscillometric blood pressure is available in three
NIBP measurement modes: spot-check, automatic interval (which measures
blood pressure routinely, at a desired interval), and stat interval
(which continually measures blood pressure for a desired duration). An
integrated port allows clinicians to connect a blood pressure cuff
inflation hose directly to Rad-97; the port is compatible with both
disposable and reusable cuffs, for adult, pediatric, and neonatal
patients.
@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 16 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://www.masimo.com/cpub/clinical-evidence.htm.
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;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™ 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-97 Pulse CO-Oximeter,
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: http://www.businesswire.com/news/home/20170918005327/en/
Source: Masimo
Masimo
Evan Lamb, 949-396-3376
[email protected]