IRVINE, Calif., Oct. 17, 2026 /PRNewswire/ — Masimo, a Danaher company and a specialty diagnostics solutions innovator of pulse oximetry and other patient monitoring solutions, today announced FDA 510(k) clearance for AFib capability on Radius VSM®. Together with its previously cleared and AI-enabled OIRD detection capability, smartSET™ expands pulse oximetry beyond individual measurements, using advanced pattern recognition and AI signal analysis to help clinicians recognize physiological changes associated with important clinical events.
Building on the industry-leading Masimo Signal Extraction Technology (SET®) pulse oximetry and more than 35 years of signal-processing innovation, smartSET represents the next evolution of SET®, extending continuous monitoring from reliable measurement to clinical insight. Its AFib and AI-enabled OIRD capabilities help clinicians identify rhythms suggestive of AFib, and physiological patterns associated with OIRD to support earlier evaluation and intervention.