New smartSET™ capability expands continuous pulse oximetry monitoring with AI-driven detection of rhythms suggestive of atrial fibrillation, alongside previously cleared opioid-induced respiratory depression detection.
Masimo, a Danaher company specializing in diagnostic and patient monitoring technologies, has announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for its atrial fibrillation (AFib) detection capability on Radius VSM®. The capability joins the previously cleared, AI-enabled opioid-induced respiratory depression (OIRD) detection feature within Masimo’s smartSET™ platform.
Built on Masimo Signal Extraction Technology (SET®) pulse oximetry and more than 35 years of signal-processing innovation, smartSET uses advanced pattern recognition and AI-based signal analysis to help clinicians identify physiological patterns associated with important clinical events. The platform aims to extend continuous pulse oximetry beyond individual measurements by providing insights that can support earlier clinical 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 at Masimo. He explained that integrating AI-driven pattern recognition into the pulse oximetry workflow can help clinicians identify subtle physiological changes earlier and provide actionable insights between routine spot checks.
Tim Benner, President of Masimo, said smartSET builds on the company’s signal-processing expertise to turn continuous monitoring data into meaningful clinical insights. He added that integrating AFib monitoring with AI-enabled OIRD detection represents an important step toward identifying serious patient risks earlier, with plans to expand the platform to address additional clinical needs.
smartSET PPG AFib Capability Supports Further Evaluation
Atrial fibrillation is a common cardiac arrhythmia that can remain undiagnosed and increase the long-term risk of stroke. According to the company announcement, AFib affects more than 10% of patients older than 65.
The smartSET photoplethysmography (PPG) AFib capability continuously analyzes pulse waveform data to identify rhythms suggestive of AFib. These indications can help clinicians determine when additional evaluation using an electrocardiogram (ECG) or telemetry may be appropriate.
In clinical validation testing, the feature demonstrated 97% sensitivity and 100% specificity, according to Masimo. The study included participants with and without AFib, including some individuals with other arrhythmias. PPG-based classifications were compared with AFib classifications made by three clinicians reviewing ECG strips collected concurrently, which served as the reference standard.
The feature is FDA-cleared to identify rhythms suggestive of AFib over a monitoring period in patients aged 18 years and older, supplementing decisions about AFib screening. It is not intended to replace traditional diagnostic or treatment methods. ECG confirmation remains necessary for diagnosing AFib.
AI-Enabled OIRD Detection Monitors Physiological Patterns
Opioid-induced respiratory depression is a significant concern in postoperative care. The company cites research indicating that approximately one in 10 surgical patients receiving opioids experiences an opioid-related adverse event, while 85% of postoperative OIRD events occur within the first 24 hours after surgery.
Although continuous monitoring can help address gaps between routine spot checks, identifying OIRD may require clinicians to recognize concerning changes across multiple physiological measurements.
The smartSET OIRD capability continuously analyzes oxygen saturation (SpO₂), pulse rate (PR) and perfusion index (Pi) in real time to assess opioid-overdose risk. By identifying physiological patterns associated with OIRD, the system generates escalating notifications on Radius VSM to alert clinicians to potentially concerning changes.
Extending Pulse Oximetry from Measurement to Clinical Insight
With AFib and OIRD capabilities integrated into a conventional pulse oximetry workflow, smartSET is designed to help clinicians recognize clinically relevant patterns in continuous monitoring data rather than relying solely on individual readings.
The combination of AI-enabled pattern recognition and continuous physiological monitoring may support more timely clinical assessment, particularly when changes develop between routine patient checks.
Healthcare organizations interested in learning more about smartSET or scheduling an evaluation can visit Masimo’s smartSET webpage or contact their Masimo representative.
About Masimo
Masimo, a Danaher company, develops specialty diagnostic and patient monitoring technologies, including measurements, sensors, patient monitors, and automation and connectivity solutions.
Introduced in 1995, Masimo SET® Measure-through Motion and Low Perfusion™ pulse oximetry has been evaluated in more than 100 independent and objective studies, according to the company. Masimo estimates that its SET technology is used on more than 200 million patients worldwide each year and identifies it as the primary pulse oximetry technology at all 10 hospitals ranked at the top of the 2026 Newsweek World's Best Hospitals listing in the United States.
More information is available at www.masimo.com.
About Danaher
Danaher is a global life sciences and diagnostics company focused on applying science and technology to improve human health. Its businesses work with customers to address scientific and clinical challenges, supporting diagnostic development and the discovery, development and delivery of therapies.
Danaher’s operating model, the Danaher Business System, combines scientific expertise, technology and continuous improvement to support innovation and operational performance. The company has approximately 60,000 associates worldwide.
More information is available at www.danaher.com.
References
-
Turakhia MP et al. PLOS ONE. 2018;13(4).
-
Masimo data on file.
-
Shafi S et al. JAMA Surgery. 2018;153(8):757–763.
-
Gupta K et al. BMJ Open. 2018;8(12).
