IRVINE, Calif.--(BUSINESS WIRE)--Dec. 19, 2016--
Masimo (NASDAQ:MASI)
announced today FDA 510(k) clearance for the TFA-1™ Single-Patient-Use
Adhesive Forehead Sensor. This single-patient-use sensor allows
clinicians to monitor patients using Masimo SET®
Measure-through Motion and Low Perfusion™ pulse oximetry from an
alternative monitoring site, the forehead, rather than a finger.
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Masimo TFA-1 Single-Patient-Use Adhesive Forehead Sensor (Photo: Business Wire)
Forehead sensors may provide oxygen saturation measurements that are
less susceptible to peripheral perfusion changes, and were shown in a
2004 study to have faster detection of desaturation and resaturation, as
compared to digit sensors.1 Forehead sensors can also be
easily accessed during surgery and resuscitation and on patients with
finger deformities or whose fingers are not accessible. As a
single-patient-use sensor, TFA-1 avoids the management complexities
(cleaning, storage, and inter-department transport) that accompany
reusable sensors.
Masimo SET® includes measurement of oxygen saturation (SpO2),
pulse rate (PR), perfusion index (PI), and PVI®, a measure of
the dynamic changes in PI that occur during the respiratory cycle.
Masimo SET® addresses the challenges of low perfusion and
motion artifact that limit conventional pulse oximetry by harnessing the
power of adaptive filters to reduce measurement inaccuracy. Masimo SET®
helps clinicians monitor more than 100 million patients a year2
and is used by 8 of the top 10 hospitals listed in the 2016-17 U.S. News
and World Report Best Hospitals Honor Roll.3
@MasimoInnovates |
#Masimo
References
1. Redford DT et al. Intraoperative Perfusion Changes at Two Pulse
Oximetry Monitoring Sites: The Digit vs. the Nare. Anesth Analg.
2004;98(2S)S-94.
2. Estimate: Masimo data on file.
3. http://health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview.
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® is estimated
to be used on more than 100 million patients in leading hospitals and
other healthcare settings around the world. 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.
Masimo is also taking an active leadership role in mHealth with products
such as the Radius-7™ wearable patient monitor and the MightySat™
fingertip pulse oximeter. Additional information about Masimo and its
products may be found at www.masimo.com.
All published clinical studies on Masimo products can be found at http://www.masimo.com/cpub/clinical-evidence.htm.
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 TFA-1™ Sensor and SET® pulse
oximetry. 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 TFA-1 Sensor and SET® pulse oximetry,
contribute to positive clinical outcomes and patient safety; risks
related to our belief that Masimo noninvasive medical breakthroughs
provide comparable accuracy 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/20161219005303/en/
Source: Masimo
Masimo
Evan Lamb, 949-396-3376
elamb@masimo.com