Business
Masimo SET® Pulse Oximetry Performed Accurately on Hospitalized Newborns of All Skin Tones in Largest-Ever Prospective Real-World Study
NICU Study Adds to the Evidence Demonstrating SET®’s Accuracy in Challenging Real-World Settings, With No Clinically Significant Differences in Performance

About this update from Masimo Corporation
[{"type":"text","content":"\nNICU 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\n\n\n IRVINE, Calif.--(BUSINESS WIRE)--\nMasimo (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\n\nThis press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260428136753/en/Masimo RD SET® Neo Pulse Oximetry Sensor\nThese 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.\n\n\nAs Dr. Siefkes’ team points out, even when conducted prospectively, with real-world patients, past studies of pulse oximetry accuracy by skin tone ...