Masimo said the U.S. Food and Drug Administration (FDA) cleared an atrial fibrillation (AFib) detection feature for its Radius VSM wearable monitor, adding a heart-rhythm alert to the device.
The FDA’s public 510(k) database lists a June 4, 2026, decision on Masimo’s submission for Radius VSM and Accessories. The record classifies the decision as “Substantially Equivalent,” but does not describe the AFib capability. Masimo announced the feature-specific clearance on Oct. 17.
Masimo says Radius VSM continuously examines photoplethysmography (PPG) pulse-waveform patterns and flags signals that may indicate AFib. The company says the feature can help clinicians decide when an electrocardiogram (ECG) or telemetry evaluation may be appropriate. It does not diagnose AFib by itself, according to Masimo.
For its clinical validation, Masimo compared the feature’s classifications with ECG strips reviewed by three clinicians. The company reported 97% sensitivity and 100% specificity. Its announcement cited company data but gave no study size or confidence intervals.
A 2018 PLOS ONE study cited by Masimo estimated AF prevalence at 10.0% among U.S. adults 65 and older in 2009, using a retrospective model of claims data. The estimate concerns an earlier U.S. population, rather than current prevalence worldwide.
Radius VSM also has a previously cleared smartSET function for opioid-induced respiratory depression (OIRD) detection, Masimo says. That feature assesses oxygen saturation, pulse rate and perfusion index, then sends escalating notifications as its risk assessment rises. Masimo’s product page says the PPG-based AFib and OIRD functions are currently available only on Radius VSM devices.
Dr. Basil Matta, Masimo’s chief medical officer, said cardiac arrhythmias can develop silently between routine checks. The announcement included no patient-outcome results showing that AFib detection changes treatment timing or health outcomes. Masimo did not specify a price, rollout geography or launch timetable.
