On October 8, 2025, Masimo Corporation announced the results of a feasibility study for its INSPIRE trial, a prospective real‑world investigation of SET® pulse oximetry performance in critically ill adults. The study, conducted at two ICUs at the Medical University of South Carolina, enrolled 50 patients and generated 80 paired SpO₂‑SaO₂ data points that met strict technical criteria.
The analysis revealed that Masimo’s SET® sensors achieved a root‑mean‑square (RMS) accuracy of 1.47 %, well within FDA specifications and significantly better than the industry standard of 3 %. The median bias between non‑invasive SpO₂ and invasive SaO₂ was –0.6 %, with no clinically significant difference between light and dark skin tone patients. Importantly, no occult hypoxemia events were observed, even though 31 of the data pairs were collected during low perfusion states (< 1.4 % perfusion).
These findings demonstrate the feasibility of conducting rigorous accuracy studies in a real‑world ICU setting and reinforce Masimo’s claim of top‑class accuracy across all skin tones. The results support the company’s ongoing regulatory strategy and position the SET® platform for broader adoption in critical care, potentially expanding its market share and strengthening its competitive moat in non‑invasive monitoring.
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