Masimo said on October 17 that FDA cleared atrial fibrillation detection on its Radius VSM wearable monitor. The feature reads photoplethysmography pulse waveforms and flags rhythms suggestive of AFib across a monitoring period. The cleared use is to supplement a screening decision in patients 18 and older.
The company reports 97 percent sensitivity and 100 percent specificity from clinical validation, with three clinicians reading concurrent ECG strips as the reference. Masimo cites data on file rather than a published study, and gave no cohort size. The label puts the output forward as a prompt for further evaluation, not a diagnosis.
The feature runs on smartSET, the analysis layer Masimo has built over its SET pulse oximetry signal processing. FDA cleared AI driven opioid induced respiratory depression detection on the same monitor in June, reading SpO2, pulse rate and perfusion index to escalate notifications. Stacking arrhythmia screening onto a monitor that is already cleared keeps the submission in predicate territory and avoids the evidence burden that comes with an ECG diagnostic claim.