Masimo Announces FDA Clearance of the Rad-67™ Pulse CO-Oximeter® with Next Generation SpHb® Spot-check Monitoring & rainb...
March 25 2019 - 8:00AM
Business Wire
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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the full release here:
https://www.businesswire.com/news/home/20190325005139/en/
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.
@MasimoInnovates | #Masimo
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.
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MasimoEvan Lamb949-396-3376elamb@masimo.com
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