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Masimo smartSET gains FDA clearance for AFib and opioid depression detection
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Fusion42 · 18 October 2026 · Fusion42 review
Masimo's smartSET pulse oximetry system gained FDA 510(k) clearance to detect atrial fibrillation (AFib) and opioid-induced respiratory depression (OIRD) in real time using AI-enhanced pattern recognition on a wearable device. This innovation supplements traditional SpO2 monitoring and targets critical patient safety gaps for postoperative and elderly patients in U.S. hospitals.
This Wire brief sits within Fusion42's coverage of Medtech.
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You can now build software that flags atrial fibrillation and opioid risks on existing pulse oximetry hardware. Masimo’s FDA clearance opens a wider market for AI-powered monitoring tools in general hospital wards where continuous telemetry isn’t standard.
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1 source · 18 Oct 2026
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