IRVINE, Calif.--(BUSINESS WIRE)--Mar. 25, 2019--
Masimo (NASDAQ:
MASI) announced today FDA clearance of the Rad-67™ Pulse CO-Oximeter®
with Spot-check Next Generation SpHb® monitoring technology
and the rainbow® DCI®-mini Reusable Sensor. Rad-67
offers rainbow® noninvasive hemoglobin measurement (SpHb) and
Measure-through Motion and Low Perfusion™ SET® pulse oximetry
in a compact, portable spot-check monitoring device. When used with the
rainbow® DCI-mini sensor, Rad-67 provides spot-check
monitoring with Next Generation SpHb.
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Masimo Rad-67™ Pulse CO-Oximeter® (Photo: Business Wire)
Next Generation SpHb technology significantly advances the forefront of
noninvasive portable hemoglobin spot-check monitoring: SpHb field
performance is enhanced across all hemoglobin ranges through faster
measurement results and improved repeatability.1
Rad-67’s ability to provide portable spot-check monitoring measurements
of both oxygen saturation and noninvasive hemoglobin makes it a
single-device solution in multiple clinical and non-clinical settings,
such as emergency rooms, pre-/post-surgery settings, and physicians’
offices. Rad-67 features a rechargeable battery with six-hour run time,
powering a high-resolution color display with intuitive touchscreen
navigation that automatically adjusts brightness to optimize visibility
in a variety of care settings. Rad-67’s feedback screens provide
real-time user guidance during SpHb measurement to help reduce error,
while the slim-profile sensor connector port is designed to provide
tactile feedback upon proper connection.
Rad-67 provides convenient historical data review directly on the
device, with unique patient identifiers to help improve organization of
records and workflow. Built-in wireless connectivity will enable data
transfer to the EMR and printing results at the point of care, which may
help reduce the likelihood of transcription errors2 or
incomplete case records.
Professor Andrew Klein, Chair of the Department of Anesthesia and
Intensive Care at Royal Papworth Hospital in Cambridge, England, and
Editor-in-Chief of Anaesthesia, commented, “The Rad-67 is
incredibly easy to use and gives a quick result, perfect in our busy
pre-operative clinic. We have found it particularly useful as it helps
us target those patients who may need further testing.”
Joe Kiani, Founder and CEO of Masimo, said, “We’re proud to launch
Rad-67, Spot-check Next Generation SpHb monitoring, and the rainbow®
DCI-mini in the United States. Spot-check Next Generation SpHb
monitoring represents a significant enhancement to the noninvasive
measurement we invented a decade ago – a measurement we look forward to
continuing to improve.”
Rad-67 spot-check SpHb monitoring is not cleared for use on pediatric
patients, pregnant patients, and patients with renal disease. SpHb is
not intended to replace laboratory blood testing. Blood samples should
be analyzed by laboratory instruments prior to clinical decision making.
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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 over 100 independent and objective studies to outperform other
pulse oximetry technologies.3 Masimo SET® has also
been shown to help clinicians reduce severe retinopathy of prematurity
in neonates,4 improve CCHD screening in newborns,5
and, when used for continuous monitoring with Masimo Patient SafetyNet™
in post-surgical wards, reduce rapid response activations and costs.6-8
Masimo SET® is estimated to be used on more than 100
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 listed in the 2018-19 U.S. News and World Report
Best Hospitals Honor Roll.10 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/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
-
Masimo field data on file.
-
The Value of Medical Device Interoperability. West Health Institute.
2013.
-
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 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.
-
Taenzer A et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia
Patient Safety Foundation Newsletter. Spring-Summer 2012.
-
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.
-
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 Masimo Rad-67™, rainbow® DCI®-mini
sensor, and Next Generation SpHb®. 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, rainbow® DCI-mini
sensor, and Next Generation SpHb, 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/20190325005139/en/
Source: Masimo
Masimo
Evan Lamb
949-396-3376
elamb@masimo.com