FDA clears AFib detection on Masimo pulse‑oximeter

The U.S. Food and Drug Administration has cleared Masimo’s smartSET pulse‑oximetry platform to detect atrial fibrillation (AFib) and alert clinicians on its Radius Vital Signs Monitor. The new feature continuously evaluates pulse waveform data and flags abnormal rhythms in real time.

Clinical Validation Data

In clinical validation, the AFib capability achieved 97 % sensitivity and 100 % specificity when compared with ECG classifications made by three independent clinicians.

Masimo was acquired by Danaher in a deal worth approximately $9.9 billion that closed in June 2026. The acquisition made Masimo a standalone entity within the Danaher portfolio.

Masimo’s chief medical officer Basil Matta said clinicians can see subtle physiological shifts earlier, bridging the gap between spot checks and providing actionable insight when minutes count. The continuous monitoring offers a more comprehensive view than intermittent checks, potentially improving early intervention for patients who deteriorate on general‑care floors.

The clearance highlights the growing role of artificial intelligence in patient monitoring, enabling early detection of arrhythmias and other critical events. Masimo’s smartSET platform already supports other AI‑enabled features, such as opioid‑induced respiratory depression detection, underscoring its versatility. This development aligns with broader efforts to integrate AI into clinical workflows, improving patient safety and outcomes.