Masimo (NASDAQ: MASI) today announced the findings of a
retrospective, peer-reviewed study published in the Journal of
Clinical Monitoring and Computing in which Dr. Vikrant Sharma,
along with Dr. Steven J. Barker, Dr. William C. Wilson, and
colleagues at Masimo performed a focused analysis of previously
published data to evaluate the impact of low perfusion on the
performance of Masimo SET® pulse oximetry across a variety of skin
pigmentations.1 The analysis demonstrated that Masimo RD SET®
sensors accurately measured oxygen saturation (SpO2) for both Black
and White subjects when perfusion index (Pi) was normal and when Pi
was low – adding to the body of evidence that Masimo SET® pulse
oximetry delivers accurate values across the skin tone range, with
no clinically significant difference in accuracy or bias, even in
challenging conditions.
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In a study published in 2023, Drs. Barker and Wilson analyzed
Masimo laboratory data obtained from self-identified Black and
White volunteer subjects to evaluate differences in Masimo pulse
oximetry accuracy and bias on the basis of skin tone. To do so,
they reviewed more than 7,000 paired data samples (collected
between 2015 and 2021) from 75 subjects (39 Black and 36 White) and
found no clinically significant difference in accuracy or
bias.2
For this newly published study, noting that low peripheral
perfusion is a “recognized confounder of conventional pulse
oximetry” and in light of concerns that low perfusion combined with
dark skin pigmentation might decrease pulse oximetry’s accuracy,
the investigators sought to determine whether accuracy on Black or
White subjects was impacted by a subject’s perfusion index (Pi)
with Masimo SET® pulse oximetry. To that end, they abstracted Pi
values from their dataset, and divided them into “low perfusion”
(Pi ≤ 1) and “normal perfusion” (Pi > 1) groups. They then
performed statistical analyses to determine bias (the mean
difference between SpO2 and arterial oxygen saturation [SaO2]),
precision (the standard deviation of the difference), and accuracy
(root-mean-square error, or ARMS*).
The researchers found that in the normal perfusion group,
comparing SpO2 to SaO2 values, there was overall bias and precision
of +0.18% ± 1.34%, with accuracy of 1.37% ARMS. For the subset of
Black subjects, there was bias and precision of -0.26% ± 1.37%, and
for White subjects, -0.12% ± 1.31%. In the low perfusion group,
there was overall bias and precision of 0.48% ± 1.59%, with
accuracy of 1.64% ARMS. For Black subjects, bias and precision were
0.19% ± 1.53%, and for White subjects, 0.91% ± 1.57%.
Based on their analysis, the authors concluded, “Masimo SET®
pulse oximeters with RD SET® sensors are accurate for individuals
of both Black and White races when Pi is normal, as well as during
conditions when Pi is low. The ARMS for all conditions studied is
well within FDA standards. This study was conducted in healthy
volunteers during well-controlled laboratory desaturations, and
results could vary under certain challenging clinical
conditions.”
However, the authors noted that controlling conditions in the
laboratory setting helps “minimize confounders that are present in
clinical scenarios, allowing for greater focus on the topics of
skin tone and Pi. Indeed, abnormal hemoglobin species (e.g.,
carboxyhemoglobin and methemoglobin) [known clinical SpO2
confounders] were measured and reported in the earlier paper by
Barker and Wilson, and the values were similar (statistically the
same) between Black and White groups.2 Also, one can only ethically
conduct desaturation studies using healthy volunteer subjects in a
safe setting.”
@Masimo | #Masimo
*ARMS accuracy is a statistical calculation of the difference
between device measurements and reference measurements.
Approximately two-thirds of the device measurements fell within +/-
ARMS of the reference measurements in a controlled study.
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. In addition, Masimo Consumer Audio is home to eight
legendary audio brands, including Bowers & Wilkins, Denon,
Marantz, and Polk Audio. Our mission is to improve life, 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.3
Masimo SET® has also been shown to help clinicians reduce severe
retinopathy of prematurity in neonates,4 improve CCHD screening in
newborns5 and, when used for continuous monitoring with Masimo
Patient SafetyNet™ in post-surgical wards, reduce rapid response
team activations, ICU transfers, and costs.6-9 Masimo SET® is
estimated to be used on more than 200 million patients in leading
hospitals and other healthcare settings around the world,10 and is
the primary pulse oximetry at 9 of the top 10 hospitals as ranked
in the 2022-23 U.S. News and World Report Best Hospitals Honor
Roll.11 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®,
Radius PPG®, and Radius VSM™, 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® and the
Masimo W1® medical watch. Masimo hospital and home automation and
connectivity solutions are centered around the Masimo Hospital
Automation™ platform, and include Iris® Gateway, iSirona™, Patient
SafetyNet, Replica®, Halo ION®, UniView®, UniView :60™, and Masimo
SafetyNet®. Its growing portfolio of health and wellness solutions
includes Radius Tº®, Masimo W1, and Masimo Stork™. Additional
information about Masimo and its products may be found at
www.masimo.com. Published clinical studies on Masimo products can
be found at www.masimo.com/evidence/featured-studies/feature/.
RPVi 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
- Sharma V, Barker S, Sorci R, Park L, Wilson W. Racial effects
on Masimo pulse oximetry: impact of low perfusion index. J Clin
Monit Comput. 19 Jan 2024.
https://doi.org/10.1007/s10877-023-01113-2.
- Barker SJ, Wilson WC. Racial effects on Masimo pulse oximetry:
a laboratory study. J Clin Monit Comput. 2023 Apr;37(2):567-574.
https://doi.org/10.1007/s10877-022-00927-w.
- 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 A 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 S 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.
- McGrath S et al. Inpatient Respiratory Arrest Associated With
Sedative and Analgesic Medications: Impact of Continuous Monitoring
on Patient Mortality and Severe Morbidity. J Patient Saf. 2020 14
Mar. DOI: 10.1097/PTS.0000000000000696.
- 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 SET®. 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 SET®, contribute to positive
clinical outcomes and patient safety; risks that the researchers’
conclusions and findings may be inaccurate; risks related to our
belief that Masimo noninvasive medical breakthroughs provide
cost-effective solutions and unique advantages; risks related to
COVID-19; 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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Masimo Evan Lamb 949-396-3376 elamb@masimo.com
Masimo (NASDAQ:MASI)
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