IRVINE, Calif.--(BUSINESS WIRE)--Jan. 29, 2018--
Masimo (NASDAQ:
MASI) announced today FDA clearance of Next Generation SedLine®
brain function monitoring. SedLine helps clinicians monitor the state of
the brain under anesthesia with bilateral acquisition and processing of
four leads of electroencephalogram (EEG) signals. Next Generation
SedLine features an enhanced signal processing engine, driving a variety
of performance improvements and helping give clinicians a more complete
picture of the brain.
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Masimo Root® with Next Generation SedLine® Brain Function Monitoring (Photo: Business Wire)
Next Generation SedLine provides an enhanced Patient State Index (PSi) –
a processed EEG parameter related to the effect of anesthetic agents –
based on its enhanced signal processing engine.
In addition, Next Generation SedLine displays an enhanced, Multitaper
Density Spectral Array (DSA), developed by Dr. Emery Brown, MD, PhD, and
Dr. Patrick Purdon, PhD, Director and Associate Director, respectively,
of the Neuroscience Statistics Research Lab at Massachusetts General
Hospital. The DSA represents activity in both sides of the brain. When
displaying a Multitaper DSA, EEG data are transformed into the frequency
domain, and may provide a better display of EEG features.
Joe Kiani, Founder and CEO of Masimo, said, “Masimo is committed to
innovation in the brain function monitoring space. With the improved
performance offered by its enhanced signal processing capabilities, we
expect Next Generation SedLine to impact brain function monitoring just
as SET® impacted pulse oximetry.”
When used with the RD SedLine™ EEG sensor, Next Generation SedLine can
be used simultaneously with O3® regional oximetry on the Root®
patient monitoring and connectivity platform for even more insight into
a patient’s brain. O3 may help clinicians monitor cerebral oxygenation
in situations in which pulse oximetry alone may not be fully indicative
of the oxygen in the brain.
@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 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 Next Generation SedLine® and O3®.
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 Next Generation SedLine and
O3, 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/20180129005445/en/
Source: Masimo
Masimo
Evan Lamb, 949-396-3376
elamb@masimo.com