IRVINE, Calif. — Masimo said a large prospective study found its SET pulse oximetry technology accurately measured oxygen levels in hospitalized newborns across all skin tones, with no clinically meaningful differences tied to pigmentation.
The findings come from the Neonatal Pulse Oximetry Accuracy and Disparities by Skin Pigmentation (NeoPODS) study, which evaluated critically ill infants in neonatal intensive care units. Researchers reported less than 1% overall statistical bias and no cases of occult hypoxemia among Black or Hispanic patients.
The study was presented at the Pediatric Academic Society meeting in Boston and published in the Journal of Pediatrics. It was led by Dr. Heather Siefkes of the University of California, Davis, in collaboration with researchers from the University of Mississippi.
“Importantly, we found no evidence of clinically meaningful skin tone-related discrepancies, suggesting equitable monitoring performance for this device in this clinical setting,” the study authors wrote.
Researchers enrolled newborn patients across two NICUs between 2022 and 2025, collecting paired measurements comparing noninvasive oxygen saturation readings with direct arterial blood measurements. The analysis included 70 patients with a range of skin tones and gestational ages.
Results showed a mean bias of about -0.98%, indicating the device slightly underestimated oxygen saturation on average rather than overestimating it. Only one instance of occult hypoxemia was identified, and it occurred in a patient with the lightest skin tone classification.
The study also found no statistically significant differences in measurement accuracy across skin pigmentation categories using multiple classification methods, including melanin index and standardized dermatological scales.
“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,” said Dr. Siefkes, the study’s principal investigator.
Masimo said the results add to previous research supporting the performance of its SET technology in challenging clinical settings, including studies involving critically ill adults.
Daniel Cantillon, M.D., Masimo’s chief medical officer, said the findings address longstanding concerns about potential disparities in pulse oximetry accuracy.
“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,” Cantillon said. “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.”
The company noted that the findings apply specifically to its device and may not extend to other pulse oximeters without similar testing in comparable patient populations.
