IRVINE, Calif.--(BUSINESS WIRE)--Oct. 27, 2015--
Masimo (NASDAQ: MASI) announced today FDA 510(k) clearance for MightySat
Rx, a fingertip pulse oximeter that incorporates Masimo SET®
Measure-through Motion and Low Perfusion™ technology.
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Masimo Announces FDA 510(k) Clearance for MightySat™ Rx Fingertip Pulse Oximeter (Photo: Business Wire)
MightySat Rx features the same Masimo SET® technology that is used in
leading hospitals worldwide and is present in all Masimo bedside devices
and in many leading multi-parameter monitors. The MightySat
noninvasively measures arterial oxygen saturation (SpO2) and pulse rate
(PR), in addition to perfusion index (PI) and optional pleth variability
index (PVI®). Masimo SET® technology enables accurate SpO2 and pulse
rate measurements during motion and low perfusion.
“We use Masimo SET® throughout our hospital, and now MightySat Rx allows
me to use Masimo SET® technology in a fingertip pulse oximeter - without
compromising on performance,” said Jon Carlson, RT, RRT-NPS, Director of
Respiratory Care Services at Mercy Hospital of Buffalo, New York. “Its
portability, durability, and convenient, small size are key. By pairing
the device with my iPhone, I can easily view my patients’ SpO2 and pulse
rate trends.”
MightySat Rx is designed to comfortably grip a patient’s finger using a
flexible, conforming silicon pad. An OLED display presents information
clearly and a touchpad allows for customization. MightySat Rx is
designed to be both rugged and lightweight.
“We are excited to provide clinicians the same accuracy provided by our
other monitors in a fingertip pulse oximeter,” said Joe Kiani, Founder
and CEO of Masimo. “The MightySat Rx is an impressive device in a very
compact form factor that provides clinicians easy access to patient
data.”
MightySat Rx is available in three versions: MightySat Rx, MightySat Rx
with Bluetooth LE, and MightySat Rx with Bluetooth LE & PVI. The
versions with Bluetooth allow iOS and Android™ mobile devices to
display, trend, and communicate the measurements made on MightySat,
using the free, downloadable Masimo Professional Health app.
For more information on MightySat Rx, go to www.masimo.com/pulseOximeter/mightysatRx.htm.
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About Masimo
Masimo (NASDAQ: MASI) is the 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. The benefits of Masimo SET® have
been proven in more than 100 independent and objective studies and it 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 Pleth Variability Index (PVI®), in addition
to SpO2, pulse rate, and perfusion index (PI). Additional information
about Masimo and its products may be found at www.masimo.com.
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 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: total hemoglobin (SpHb®) contribute to positive
clinical outcomes and patient safety; risks related to our belief that
Masimo noninvasive medical breakthroughs provide cost-effective
solutions with comparable accuracy and unique advantages, including:
immediate and continuous results that enable earlier treatment without
causing invasive trauma in all patients and in every clinical situation;
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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Source: Masimo
Masimo
Irene Paigah, 858-859-7001
irenep@masimo.com