Masimo won FDA 510(k) clearance for an atrial fibrillation feature on its Radius VSM wearable, letting the device carry two AI-driven warnings on one continuous signal.
The new capability reads the pulse waveform already collected by Masimo SET pulse oximetry and looks for rhythms consistent with AFib. Its clinical validation returned 97% sensitivity and 100% specificity, measured against three clinicians reading concurrent ECG strips as ground truth.
Masimo says the tool suggests further evaluation rather than diagnosing. Clinicians still need an ECG or telemetry strip to confirm the arrhythmia, and the clearance covers screening in patients 18 and older.
The stakes are structural. AFib affects more than 10% of people over 65 and often surfaces only after a stroke. On the general care floor, arrhythmias and respiratory compromise tend to build quietly between rounds, when no one is watching a raw number.
Pairing AFib with the previously cleared AI opioid-induced respiratory depression detection gives smartSET two pattern-recognition jobs. The OIRD side continuously weighs oxygen saturation, pulse rate and perfusion index, then escalates notifications on the wearable. Masimo cites one opioid-related adverse event in every 10 surgical patients receiving opioids, with 85% of postoperative OIRD cases arriving inside the first 24 hours.
“When a patient deteriorates on a general care floor, respiratory compromise and cardiac arrhythmias often develop silently between routine rounds,” said Basil Matta, Masimo’s chief medical officer.
Distribution will not be the constraint. Masimo SET is already the primary pulse oximetry platform at all 10 top-ranked U.S. hospitals in the 2026 Newsweek World’s Best Hospitals list, so post-market data should arrive fast.
That exposure cuts both ways. How the AFib flag behaves in inpatients with other arrhythmias is the number to watch once the clearance reaches real ward populations.
