Smart Pulse Oximetry Supports Earlier Recognition of Arrhythmias and Respiratory Risk

Atrial fibrillation often goes undiagnosed in older adults, while opioid-induced respiratory depression is most likely early after surgery. Continuous monitoring may enable earlier recognition and intervention. A new system supports this approach by combining AI with continuous pulse oximetry to flag rhythms suggestive of atrial fibrillation and patterns associated with opioid-induced respiratory depression.

Masimo’s smartSET pulse oximetry expands continuous monitoring beyond individual measurements by adding AI-enabled capabilities that help clinicians recognize physiologic changes associated with important events. Built on Signal Extraction Technology (SET) pulse oximetry and available on the Radius VSM wearable monitor, the platform is designed to provide earlier clinical insight while maintaining a familiar pulse oximetry workflow.

The smartSET photoplethysmography (PPG) atrial fibrillation (AFib) capability continuously analyzes the pulse waveform to identify rhythms suggestive of AFib and indicate when additional electrocardiogram or telemetry evaluation may be appropriate. In parallel, the AI-enabled opioid-induced respiratory depression (OIRD) feature continuously analyzes oxygen saturation (SpO₂), pulse rate (PR), and perfusion index (Pi) in real time to assess opioid overdose risk. When patterns associated with OIRD are detected, the system generates escalating notifications on Radius VSM.

The AFib capability on Radius VSM has received U.S. Food and Drug Administration (FDA) 510(k) clearance. The PPG-based feature is cleared to identify rhythms suggestive of atrial fibrillation over a monitoring period in adults aged 18 years and older, helping inform decisions about whether further AFib screening may be needed. It is not intended to replace traditional diagnostic or treatment methods, and any alert is meant to prompt additional clinical evaluation rather than provide a definitive diagnosis.

In clinical validation testing, the AFib capability demonstrated sensitivity of 97% and specificity of 100% when its classifications were compared with ground-truth AFib determinations from three clinicians who reviewed concurrently collected electrocardiogram strips. AFib affects more than 10% of patients over age 65 and often remains undiagnosed, increasing long-term stroke risk. Among surgical patients receiving opioids, one in ten experiences an opioid-related adverse event, and 85% of postoperative OIRD events occur within the first 24 hours after surgery.

“When a patient deteriorates on a general care floor, respiratory compromise and cardiac arrhythmias often develop silently between routine rounds. 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,” said Dr. Basil Matta, Chief Medical Officer, Masimo.