Rad-97 Comes with Advanced Communication Capabilities to Facilitate
Telehealth
IRVINE, Calif.--(BUSINESS WIRE)--Jan. 9, 2018--
Masimo (NASDAQ:
MASI) announced today FDA clearance for home use of the Rad-97™ Pulse
CO-Oximeter®. 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 combines advanced connectivity and
communication capabilities for telehealth with an interface easily
customized for use at home.
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Masimo Rad-97™ Pulse CO-Oximeter® with Optional Integrated Camera (Photo: Business Wire)
With an ever increasing number of patients receiving care at home, there
is a growing need for high-quality home monitoring and telehealth
equipment. Rad-97, in addition to SET® pulse oximetry and
advanced parameter monitoring technology through rainbow®
noninvasive monitoring, is available with optional integrated blood
pressure and capnography measurements. Its innovative communication
capabilities allow monitoring data from a variety of third-party
Bluetooth®-enabled devices used at home, including
thermometers, weight scales, and glucometers, to seamlessly transfer to
Rad-97 – and from there to anywhere in the world, in real time. The
optional integrated camera allows remote clinicians to interact with
patients over live audio and video. Rad-97 brings hospital-grade
technology to the home in a single, integrated device that is a
monitoring, connectivity, and telecommunications hub.
With its built-in enterprise WiFi capability, Rad-97 has the ability to
connect wirelessly from the home to supplemental patient monitoring
systems in the hospital, including Masimo Patient SafetyNet™*, allowing
clinicians to remotely observe patient status while facilitating
automatic data transfer to hospital electronic medical record (EMR)
systems. Rad-97 can trend and store data for up to 96 hours.
With its intuitive touchscreen interface, Rad-97 is easy to use for
clinicians and non-clinicians alike, and can be easily customized to
meet the needs of home users. The device can be configured in Home mode,
which streamlines basic utility, giving home users access to applicable
settings and messages, while hiding others and locking alarm settings,
minimizing the chances of inadvertent interaction.
Joe Kiani, Founder and CEO of Masimo, said, “Rad-97 is well-suited for a
variety of care settings, now including home. Facilitated by its
powerful connectivity and telehealth capabilities, Rad-97 allows
clinicians to remotely interact with patients, as well as monitor their
status and spot trends from afar through automated data collection and
transfer.”
@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://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;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™. 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, 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/20180109005756/en/
Source: Masimo
Masimo
Evan Lamb, 949-396-3376
elamb@masimo.com