Masimo’s smartSET™ FDA Clearance Offers Breakthrough Innovation in Pulse Oximetry to Help Improve Critical Patient Outcomes
Industry-Leading Pulse Oximetry Platform Now Features First-of-Its-Kind Atrial Fibrillation (AFib) Detection with Previously Cleared AI-Enabled Opioid-Induced Respiratory Depression (OIRD) Detection Designed Together to Deliver Earlier Clinical Insights
IRVINE, Calif., Oct. 17, 2026 /PRNewswire/ — Masimo, a Danaher company and a specialty diagnostics solutions innovator of pulse oximetry and other patient monitoring solutions, today announced FDA 510(k) clearance for AFib capability on Radius VSM®. Together with its previously cleared and AI-enabled OIRD detection capability, smart SET™ expands pulse oximetry beyond individual measurements, using advanced pattern recognition and AI signal analysis to help clinicians recognize physiological changes associated with important clinical events.
Building on the industry-leading Masimo Signal Extraction Technology (SET®) pulse oximetry and more than 35 years of signal-processing innovation, smart SET represents the next evolution of SET®, extending continuous monitoring from reliable measurement to clinical insight. Its AFib and AI-enabled OIRD capabilities help clinicians identify rhythms suggestive of AFib, and physiological patterns associated with OIRD to support earlier evaluation and intervention.
“When a patient deteriorates on a general care floor, respiratory compromise and cardiac arrhythmias often develop silently between routine rounds,” said Dr. Basil Matta, Chief Medical Officer, Masimo. “By bringing AI-driven pattern recognition directly into the pulse oximetry workflow, smart SET helps clinicians see subtle physiological shifts earlier. It bridges the gap between spot checks, giving care teams actionable insight when minutes count.”
“For more than three decades, Masimo has expanded what clinicians can expect from pulse oximetry,” said Tim Benner, President, Masimo. “With smart SET, we are bringing intelligent sensing and AI-enabled detection to the bedside—building on our signal-processing expertise to turn continuous monitoring data into meaningful clinical insight. The addition of AFib monitoring to smart SET, alongside AI-enabled OIRD detection, represents a major leap forward to empower clinicians with earlier visibility into serious patient risks before symptoms escalate. Looking ahead, we intend to continue expanding the smart SET platform to address other critical clinical needs. This is how we advance innovation—by focusing on the information clinicians need to care for patients.”
Recognizing Rhythms Suggestive of AFib
AFib affects more than 10% of patients over age 65 and often remains undiagnosed, significantly increasing the long-term risk of stroke. The smart SET PPG AFib capability continuously analyzes pulse waveform data to identify rhythms suggestive of AFib, helping clinicians determine when additional electrocardiogram (ECG) or telemetry evaluation may be appropriate. The capability provides an indication for further clinical evaluation; it does not replace ECG confirmation of AFib.
In the clinical validation testing, the AFib capability demonstrated sensitivity and specificity of (97% and 100%, respectively). The study included cohorts with AFib and without AFib, including some with other arrhythmias. The study was conducted comparing the PPG AFib feature classifications against those made by 3 different clinicians reviewing the concurrently collected ECG strips as the ground truth for an AFib classification.
Helping Clinicians Recognize and Respond to OIRD
1 in 10 surgical patients receiving opioids experience an opioid-related adverse event, while 85% of postoperative OIRD events occur within the first 24 hours after surgery. Continuous monitoring helps address the gaps between routine spot checks; however, identifying OIRD can still depend on recognizing concerning trends in the data. The smart SET OIRD capability continuously analyzes oxygen saturation (SpO₂), pulse rate (PR), and perfusion index (Pi) in real time to assess opioid overdose risk. By identifying patterns associated with OIRD, the system generates escalating notifications on Radius VSM and is designed to provide clinicians with peace of mind.
From Signal Processing to Clinical Insight
With AFib and OIRD capabilities available within a traditional pulse oximetry workflow, smart SET expands the clinical information clinicians can obtain from continuous pulse oximetry monitoring by moving beyond individual measurements to automated detection, helping clinicians identify clinically relevant patterns.
Healthcare organizations interested in learning more or scheduling an evaluation can visit the smart SET webpage or contact their Masimo representative.
