FDA clears AFib detection feature on advanced pulse oximetry system

Masimo, a California-based medtech company, has secured U.S. Food and Drug Administration (FDA) clearance for its smartSET pulse oximetry platform to identify signs of atrial fibrillation (AFib) and deliver alerts to its Radius Vital Signs Monitor. The newly cleared feature continuously evaluates a patient’s pulse waveform data, flagging clinicians when additional follow-up care may be necessary.

“When a patient deteriorates on a general care floor, respiratory compromise and cardiac arrhythmias often develop silently between routine rounds,” Basil Matta, BA, MB, BCh, BAO, Masimo chief medical officer, said in a statement. “By bringing AI-driven pattern recognition directly into the pulse oximetry workflow, smartSET helps clinicians see subtle physiological shifts earlier. It bridges the gap between spot checks, giving care teams actionable insight when minutes count.”

“For more than three decades, Masimo has expanded what clinicians can expect from pulse oximetry,” added Tim Benner, Masimo president. "With smartSET, we are bringing intelligent sensing and AI-enabled detection to the bedside—building on our signal-processing expertise to turn continuous monitoring data into meaningful clinical insight.”