IRVINE, Calif. - Tuesday, 28. April 2026
NICU
Study Adds to the Evidence Demonstrating SET®’s Accuracy in Challenging
Real-World Settings, With No Clinically Significant Differences in
Performance Across Skin Pigmentation Categories or Race and Zero Occult
Hypoxemia in Black or Hispanic Newborns
(BUSINESS WIRE) -- Masimo
(NASDAQ: MASI) today announced the findings of a study evaluating the
accuracy of Masimo SET® pulse oximetry among critically ill neonates and
demonstrating less than 1% overall statistical bias. Importantly, there
were no clinically meaningful skin pigmentation-related discrepancies
and no occult hypoxemic events among Black or Hispanic patients, and in
only one Caucasian patient overall. The Neonatal Pulse Oximetry Accuracy
and Disparities by Skin Pigmentation (NeoPODS) study findings were
presented from the podium at the Pediatric Academic Society in Boston,
MA on Monday, April 27th at 10 am EST by lead author Dr. Heather Siefkes
on behalf of colleagues at the University of California, Davis and the
University of Mississippi, Jackson, alongside online publication in the
Journal of Pediatrics. As the authors noted, “[W]e found no evidence of
clinically meaningful skin tone-related discrepancies, suggesting
equitable monitoring performance for this device in this clinical
setting.”1
These promising results—from an NIH-funded study that
exclusively evaluated Masimo SET® in a vulnerable, clinically fragile
patient population—add to previously published evidence of its strong
performance under the most challenging real-world conditions across all
skin tones. The INSPIRE feasibility study, published late last year,
showed that SET® pulse oximetry performed accurately on critically ill
adult medical ICU patients of all skin tones, without any occult
hypoxemic events2—results similar to the newly published NICU findings,1
as well as prior evaluations of Masimo SET®’s accuracy by skin tone.3-6
The results of the full INSPIRE study—involving approximately 500 adult
patients—are expected to be published later this year.
As Dr.
Siefkes’ team points out, even when conducted prospectively, with
real-world patients, past studies of pulse oximetry accuracy by skin
tone in newborns have not used quantitative, objective measurements to
classify pigmentation, or have other methodological shortcomings and
limitations. Some prior studies have found that oxygen saturation
measured by noninvasive pulse oximetry (SpO2) can overestimate arterial
blood oxygen saturation (SaO2), which can lead to occult hypoxemia.
Noting that accurate detection of hypoxemia is especially important in
NICU patients, since it drives many care pathway decisions, the NeoPODS
researchers thus set out to conduct a prospective accuracy study in this
patient population, hospitalized NICU patients, with rigorous technical
methodology: tightly paired, time-synchronized SpO2-SaO2 measurements
and objectively classified skin pigmentation across a range of
gestational ages using the same sensors and monitors for all patients.
Their primary outcome was the mean bias between paired, simultaneously
measured SpO2 and SaO2 values, and their secondary outcome,
understanding how that bias differed by skin tone.
The
researchers enrolled patients between July 2022 and July 2025 at two
tertiary NICUs at UC Davis and UM Jackson. The patients were
hospitalized newborns up to ten days old, of at least 26 weeks
gestational age, with an indwelling arterial catheter and at least one
clinically indicated arterial blood draw. Masimo RD SET® Neo sensors
connected to Radical-7® Pulse CO-Oximeters® and Root® monitoring
platforms were used to continuously record SpO2 data before, during, and
after arterial blood gas (ABG) sampling. SaO2 values were directly
measured with on-site laboratory analyzers and then paired with the
corresponding average SpO2 for the 30 seconds preceding each blood draw.
In addition to recording parent-reported race, each patient’s skin tone
classification was objectively assessed with a variety of methods,
including melanin index and individual typology angle (ITA)—the latter a
continuous, quantitative measure of skin pigmentation recommended by
the FDA in their 2025 draft guidance for pulse oximeter manufacturers.7
Data was captured by a SkinColorCatch device, and visual scoring was
performed by clinicians blinded to each other’s observations using the
Massey-Martin and the Fitzpatrick scales.
From among 100 newborns
enrolled over the three years, 136 paired SpO2-SaO2 readings collected
from 70 patients met the technical criteria for inclusion in the final
analysis. The patients’ median gestational age was 28.4 weeks and median
gestational weight was 1085 grams (very low birth weight). As
identified by their parents, 40% of the patients were Black and 23% were
Hispanic. As objectively assessed, their skin pigmentations spanned the
full range of ITA classifications and most, but not the darkest, points
of the Massey-Martin and Fitzpatrick scales.
The researchers
found that overall mean bias between noninvasive SpO2 and invasive SaO2
was -0.98% 2.80% (95% confidence interval, -1.45% to -0.52%), which is
not a clinically significant amount, and means that, on average, SpO2
slightly underestimated, not overestimated, SaO2. In fact, there was
only one data pair meeting the definition of occult hypoxemia
(SaO2<88% when SpO2≥92%), collected from a patient with the lightest
ITA skin tone classification; there were zero cases of occult hypoxemia
among Black or Hispanic patients.
Turning to accuracy by skin
pigmentation, the researchers found that across the objective
classification measurements, as well as parent-reported race, there were
no statistically or clinically significant differences in mean
SpO2-SaO2 bias. For melanin index and ITA classification, when analyzed
continuously, bias became slightly less negative with lighter skin
pigmentation, but with statistical significance only when ITA analysis
was restricted to each patient’s first measurement. There was no
significant difference in bias comparing the 3 darkest to the 3 lightest
ITA classifications, with all categories except the lightest showing a
small negative bias and no statistically significant trend in bias with
increasing darkness or lightness. Analyzing bias by Fitzpatrick and
Massey-Martin classifications, the researchers similarly found no
statistically significant differences (including when analysis was
restricted to the first data pair per patient).
The authors
concluded that their study is “a novel prospective study of newborns
using objective skin pigmentation and closely paired SpO2 and SaO2
measurements assessing pulse oximeter accuracy across skin tones. Our
study did not find clinically meaningful pigmentation-related bias. We
believe this study provides some reassurance on equitable and accurate
care in the NICU for this specific device and population. Our study
supports the need for additional age-specific and device-specific pulse
oximeter performance assessments.”
Heather Siefkes, M.D.,
Principal Investigator of the NeoPODS study and Associate Professor at
the University of California Davis Children’s Hospital, commented, “In
this prospective study of critically ill newborns with tightly paired
measurements, we found that pulse oximetry only slightly underestimated
arterial oxygen saturation overall and did not demonstrate clinically
meaningful differences across skin pigmentation. Bias varied with oxygen
saturation, with a tendency toward overestimation at lower SaO2 levels;
however, this pattern was not modified by skin pigmentation. Our
findings highlight the importance of continued age-, disease-, and
device-specific evaluation of pulse oximeter performance.”
Daniel
Cantillon, M.D., Chief Medical Officer at Masimo, added, “Concerns
about occult hypoxemia in vulnerable neonates, especially with darker
skin tones, prompted this large, investigator-initiated and NIH funded
real-world study applying rigorous scientific methods. Once again, we’re
highly encouraged to see Masimo's RD SET technology demonstrate less
than 1% overall bias without occult hypoxemic events among Black or
Hispanic infants. This is consistent with the recently published INSPIRE
feasibility study results among critically ill adults in the ICU under
similarly challenging conditions. However, as the authors note, these
findings cannot be extrapolated to other pulse oximeter manufacturers
untested on critically ill patients under real-world conditions.”
@Masimo | #Masimo
References
Siefkes
H, Holla I, Giusto E, Tancredi D, and Lakshminrusimha S. Neonatal Pulse
Oximetry Accuracy and Disparities by Skin Pigmentation (NeoPODS): A
Prospective Study. J Ped. 21 Apr 2026. doi: 10.1016/j.jpeds.2026.115114
Travers
A, Terry C, Merrell W, Heincelman M, Warden A, Goodwin A. INSPIRE:
Feasibility of a Study Examining the Effect of Skin Pigment on Pulse
Oximetry. CHEST Crit Care. 10 Sept 2025. DOI:
10.1016/j.chstcc.2025.100209.
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.
Foglia EE, Whyte RK,
Chaudhary A, Mott A, Chen J, Propert KJ, Schmidt B. The Effect of Skin
Pigmentation on the Accuracy of Pulse Oximetry in Infants with
Hypoxemia. J Pediatr. 2017 Mar;182:375-377.e2.
https://doi.org/10.1016/j.jpeds.2016.11.043.
Marlar AI, Knabe BK,
Taghikhan Y, Applegate RL, Fleming NW. Performance of pulse oximeters
as a function of race compared to skin pigmentation: a single center
retrospective study. J Clin Monit Comput. 2025 Feb;39(1):119-125.
https://doi.org/10.1007/s10877-024-01211-9.
Pulse Oximeters for
Medical Purposes – Non-Clinical and Clinical Performance Testing,
Labeling, and Premarket Submission Recommendations. Draft Guidance for
Industry and Food and Drug Administration Staff. January 7, 2025.
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 for our
innovations to empower clinicians to transform patient care. Masimo SET®
Measure-through Motion and Low Perfusion™ pulse oximetry, introduced in
1995, has been shown to outperform other pulse oximetry technologies in
over 100 independent and objective studies, which can be found at
www.masimo.com/evidence/featured-studies/feature. Masimo SET® is
estimated to be used on more than 200 million patients around the world
each year and is the primary pulse oximetry at all 10 top U.S. hospitals
as ranked in the 2026 Newsweek World’s Best Hospitals listing.
Additional information about Masimo and its products may be found at
www.masimo.com.
Forward-Looking Statements
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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. Forward-looking statements are statements other than
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result of various risk factors, including, but not limited to: the
ability for clinical studies to recruit eligible participants; the
ability for the investigator to collect meaningful data; the design of
the clinical protocol; and other factors discussed in the “Risk Factors”
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Contacts
Masimo
Christine McCullough
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christine.mccullough@masimo.com
Evan Lamb
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elamb@masimo.com
