Announcement • Apr 30

Masimo Announces Accuracy of Set Pulse Oximetry on Hospitalized Newborns of All Skin Tones

Masimo 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. 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 events—results similar to the newly published NICU findings, as well as prior evaluations of Masimo SET’s accuracy by skin tone. The results of the full INSPIRE study—involving approximately 500 adult patients—are expected to be published later this year. 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. 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. 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 1,085 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. 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.

Announcement • Oct 07

Masimo Announces the Findings of an Exploratory Analysis for A Unique Feasibility Study Published in Chest Critical Care

Masimo announced the findings of an exploratory analysis for a unique feasibility study published in CHEST Critical Care in which Dr. Andrew Goodwin and colleagues at the Medical University of South Carolina (MUSC) found that Masimo SET®? pulse oximetry performed accurately among critically ill adult patients of all skin tones, including those with low perfusion requiringvasopressors - and reported zero occult hypoxemic events. Such accuracy studies are typically conducted in controlled laboratory conditions with healthy volunteers, or using retrospective data from hospitalized patients. Such technical rig was evaluated using data collected from the first 50 of a planned 502 patients. In this dataset, they found that Masimo SET pulse oximetry was accurate among patients of all skin tones—well within FDA specifications for laboratory studies—when compared with arterial blood samples. The modest median bias between SpO2 and SaO2 was not clinically significant, and nor was there a clinically significant difference between the median biases for light and dark skin tone patients. In the present analysis, the researchers enrolled 107 adult patients at two ICUs within the MUSC main hospital from January to July 2024, which yielded a sample size of 50 patients who had at least one clinically indicated blood draw collected while the study team was present. Skin pigmentation was assessed using a validated noninvasive hand-held skin colorimeter, with patients grouped into dark and light skin tone categories based on individual topology angle (ITA). SpO2 readings were collected using Masimo RD SET sensors connected to Rad-97 Pulse CO-Oximeters. From among the 50 patients and 84 blood samples in the sample size, the researchers found that 80 paired SpO2-SaO2 readings from 49 patients met their technical criteria for inclusion. The patients also met INSPIRE’s skin pigmentation requirement, representing a wide range of ITA measurements and all 6 ITA categories. 26 of the 50 patients were classified as having dark skin pigmentation, with 41 data pairs from patients with dark skin tone and 39 from patients with light skin tone. 31 data pairs (39%) were collected from patients during low perfusion (The researchers found that, among the 49 patients and 80 data pairs, Masimo SET pulse oximetry had overall accuracy of 1.47% root-mean-squared (ARMS*), in keeping with the FDA accuracy specification for Masimo RD SET sensors in no motion and motion conditions, 1.5% ARMS, and significantly outperforming the industry-standard specification of 3% ARMS. The median bias between noninvasive SpO2 and invasive SaO2 was -0.6%, which is not clinically significant. There was a modest, statistically but not clinically significant, difference of 0.7% between the median bias for dark skin tone and light skin tone patients (-0.2% vs. -0.9%; p=0.0004). While nearly half of the data pairs were collected from subjects at risk of occult hypoxemia, zero occult hypoxemic events occurred. Data collection for the full INSPIRE trial is still in progress. In the full study, the result of which the researchers hope to publish next year, they will investigate and analyze the effect of skin pigmentation on pulse oximeter accuracy across the complete dataset, including a comparison of occult hypoxemia rates between patients with dark and light skin tones.

Interest coverage ratio	11.6x
Cash	US$124.60m
Equity	US$788.90m
Total liabilities	US$853.80m
Total assets	US$1.64b

Data	Last Updated (UTC time)
Company Analysis	2026/06/09 21:12
End of Day Share Price	2026/06/09 00:00
Earnings	2026/04/04
Annual Earnings	2026/01/03

Package	Data	Timeframe	Example US Source ^*
Company Financials	10 years	Income statement Cash flow statement Balance sheet	SEC Form 10-K SEC Form 10-Q
Analyst Consensus Estimates	+3 years	Forecast financials Analyst price targets	Analyst Research Reports Blue Matrix
Market Prices	30 years	Stock prices Dividends, Splits and Actions	ICE Market Data SEC Form S-1
Ownership	10 years	Top shareholders Insider trading	SEC Form 4 SEC Form 13D
Management	10 years	Leadership team Board of directors	SEC Form 10-K SEC Form DEF 14A
Key Developments	10 years	Company announcements	SEC Form 8-K

Analyst	Institution
Michael Polark	Baird
Charley Jones	Barrington Research Associates, Inc.
Ravi Misra	Berenberg

This company has been acquired

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