Masimo Reports <1% Bias in Newborn Pulse Oximetry, Zero Occult Events in Black, Hispanic Infants
Masimo demonstrated less than 1% overall bias in its SET pulse oximetry readings across 136 paired SpO2-SaO2 measurements from 70 critically ill newborns, with only one occult hypoxemic event observed in a light-skinned patient. No clinically significant skin pigmentation-related discrepancies occurred among Black or Hispanic infants.
1. Study Design and Methodology
Masimo’s NeoPODS study enrolled 100 newborns up to ten days old, with gestational ages of at least 26 weeks, at two NICUs between July 2022 and July 2025. The study collected 136 paired SpO2 and SaO2 measurements using RD SET® Neo sensors on Radical-7® and Root® platforms, with skin pigmentation classified both objectively (melanin index, ITA) and visually (Massey-Martin, Fitzpatrick scales).
2. Overall Accuracy Results
The overall mean bias between noninvasive SpO2 and invasive SaO2 was -0.98% ± 2.80%, indicating slight underestimation of arterial oxygen saturation. Among all readings, only one occult hypoxemic event (SaO2 < 88% when SpO2 ≥ 92%) occurred in a light-skinned infant, with zero such events in Black or Hispanic patients.
3. Skin Pigmentation Analysis
Analysis across quantitative ITA and melanin index measures, as well as Massey-Martin and Fitzpatrick scales, revealed no statistically or clinically significant differences in SpO2-SaO2 bias by skin pigmentation. Bias trended marginally less negative with lighter skin only in first measurements by ITA but showed no meaningful trend across categories.
4. Clinical Implications and Next Steps
These results reinforce equitable monitoring performance of Masimo SET® pulse oximetry in the NICU and address concerns of occult hypoxemia by skin tone. Full adult INSPIRE study results, involving around 500 ICU patients, are expected later this year, potentially broadening the evidence base for Masimo’s technology under challenging conditions.