Masimo Gets FDA Clearance for AFib Detection on Radius VSM

Oct 17, 2026
Masimo received FDA 510(k) clearance for an atrial fibrillation detection feature on its Radius VSM patient monitor. The feature continuously analyzes pulse waveform data and identifies rhythms that may require further evaluation.

Masimo announced in a press release that it received FDA 510(k) clearance for an atrial fibrillation detection feature on its Radius VSM patient monitor. The feature is part of the smartSET pulse oximetry platform and continuously analyzes photoplethysmography pulse waveform data for rhythms suggestive of AFib.

The feature is intended to support screening decisions for adults and indicate when an electrocardiogram or telemetry assessment may be appropriate. It does not replace ECG confirmation. In Masimo's own clinical validation testing, the feature showed 97% sensitivity and 100% specificity, measured against classifications from three clinicians who reviewed concurrently collected ECG strips.

SmartSET also includes a previously cleared AI enabled feature for detecting patterns associated with opioid induced respiratory depression. That capability analyzes oxygen saturation, pulse rate, and perfusion index, then issues escalating notifications through Radius VSM.

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