Masimo (NASDAQ: MASI) announced today that after a decade
of developing and testing its comprehensive, scalable, and
customizable continuous early warning score, with the aid of
leading expert clinicians around the world, it is releasing Halo
ION™. Halo ION allows clinicians to aggregate trend data from as
few as three physiological parameters (oxygen saturation, pulse
rate, and perfusion index), and as many as are available, including
data from EMRs, into a single continuous early warning score. Each
patient’s Halo ION score is displayed on the Masimo Patient
SafetyNet™ Supplemental Remote Monitoring and Clinician
Notification System as a number ranging from zero to 100, helping
to streamline clinicians’ patient assessment workflow.
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Masimo Patient SafetyNet™ with Halo ION™
(Photo: Business Wire)
What is difficult for people is easy for Halo ION: in
calculating scores, Halo ION not only takes advantage of
immediately available patient data, but more importantly, keeps
track of historical physiological data and data from other records.
Halo ION thus helps to automate the process by which clinicians
assess patient status over time, providing a cumulative, trended
score for each patient, easily visible on the Patient SafetyNet
View Stations or Replica™ mobile application, configured according
to their clinical protocols, that can help facilitate their
determination of a patient’s overall status. Trends in Halo ION
scores, which are calculated according to how the hospital has
chosen to configure Halo ION, help clinicians evaluate whether
patients are improving or deteriorating according to their own
criteria. Clinicians may then use this information to, for example,
intervene with certain patients, to transfer or discharge certain
patients, and to schedule nursing assignment loads accordingly.
Halo ION works by continuously extracting key characteristics
from clinician-selected parameters that are continuously monitored
on the Root® Patient Monitoring and Connectivity Hub and anything
connected to Root – such as oxygen saturation (SpO2 using Masimo
SET® pulse oximetry), noninvasive hemoglobin (SpHb®), blood
pressure, temperature, and pulse rate – to create an overall score.
Hospitals and clinicians determine which parameters to include in
the overall score, how each is configured, how each is weighted,
and how combinations of changes across multiple parameters affect
scoring – providing the flexibility and customizability to ensure
that Halo ION reflects each institution’s assessment policy.
Unlike other Early Warning Score assessment tools, which take
spot-check snapshots of patient vital signs, Halo ION provides
cumulative, continuous visibility into patient status over time,
taking into account not only historical trend data for each
parameter but also more complex characteristics, such as a
parameter’s degree of stability and variability. Halo ION creates
individualized, patient-specific baseline scores for each parameter
– not global, one-size-fits-all thresholds – and tracks how each
patient deviates from their baselines, adjusting the overall Halo
ION score differently for different patients. For example, the Halo
ION score might be different for two patients whose oxygen
saturation drops to 89% if one patient normally has 100% SpO2 and
the other 94%; those different deltas would be reflected in
different amounts of change in their Halo ION scores.
Joe Kiani, Founder and CEO of Masimo, commented, “Precision
medicine is no longer only about the right drug for the right
patient based on their genetics, but also about individualized
assessment of their state of health. Halo ION represents many years
of research into how best to take the complex, almost overwhelming
stream of high quality physiological data available to clinicians
and present it in a way that is intuitive, efficient, and provides
individualized insight into a patient’s overall status. With its
unique ability to create patient-specific baselines and to take
into account many subtle changes over time, Halo ION helps automate
and simplify the process of patient assessment, helping clinicians
stay focused on providing the best care for their patients.”
@MasimoInnovates | #Masimo
About Masimo
Masimo (NASDAQ: MASI) is a global medical technology company
that develops and produces a wide array of industry-leading
monitoring technologies, including innovative measurements,
sensors, patient monitors, and automation and connectivity
solutions. Our mission is to improve patient outcomes and reduce
the cost of care. Masimo SET® Measure-through Motion and Low
Perfusion™ pulse oximetry, introduced in 1995, has been shown in
over 100 independent and objective studies to outperform other
pulse oximetry technologies.1 Masimo SET® has also been shown to
help clinicians reduce severe retinopathy of prematurity in
neonates,2 improve CCHD screening in newborns,3 and, when used for
continuous monitoring with Masimo Patient SafetyNet™ in
post-surgical wards, reduce rapid response activations and
costs.4-6 Masimo SET® is estimated to be used on more than 100
million patients in leading hospitals and other healthcare settings
around the world,7 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.8 Masimo continues to refine SET® and in
2018, announced that SpO2 accuracy on RD SET™ sensors during
conditions of motion has been significantly improved, providing
clinicians with even greater confidence that the SpO2 values they
rely on accurately reflect a patients’ physiological status. 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®), RPVi™ (rainbow® PVi) and Oxygen Reserve
Index (ORi™). In 2013, Masimo introduced the Root® Patient
Monitoring and Connectivity Platform, built from the ground up to
be as flexible and expandable as possible to facilitate the
addition of other Masimo and third-party monitoring technologies;
key Masimo additions include Next Generation SedLine® Brain
Function Monitoring, O3® Regional Oximetry, and ISA™ Capnography
with NomoLine® sampling lines. Masimo’s family of continuous and
spot-check monitoring Pulse CO-Oximeters® includes devices designed
for use in a variety of clinical and non-clinical scenarios,
including tetherless, wearable technology, such as Radius-7®,
portable devices like Rad-67™, fingertip pulse oximeters like
MightySat® Rx, and devices available for use both in the hospital
and at home, such as Rad-97™. Masimo hospital automation and
connectivity solutions are centered around the Iris® platform, and
include Iris Gateway™, Patient SafetyNet, Replica™, Halo ION™,
UniView™, and Doctella™. 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 and RPVi have not received FDA 510(k) clearance and are not
available for sale in the United States. The use of the trademark
Patient SafetyNet is under license from University HealthSystem
Consortium.
References
- 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 Halo ION™. 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 Halo ION, 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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