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, smartSET™ 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, smartSET 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, smartSET 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 smartSET, 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 smartSET, 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 smartSET 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 stroke1. The smartSET 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).2 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 event3, while 85% of postoperative OIRD events occur within the first 24 hours after surgery4. Continuous monitoring helps address the gaps between routine spot checks; however, identifying OIRD can still depend on recognizing concerning trends in the data. 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 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, smartSET 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 smartSET webpage or contact their Masimo representative.
References
- Turakhia MP et al. PloS One. 2018;13(4):e0195088.
- Masimo data on file.
- Shafi S et al. JAMA Surg. 2018;153(8):757-763.
- Gupta K et al. BMJ Open. 2018;8(12).
Masimo PPG AFib feature is FDA cleared to identify rhythms suggestive of atrial fibrillation (AFib) over a monitoring period to supplement the decision for AFib screening in patients 18 years or older. The feature is not intended to replace traditional methods of diagnosis or treatment.
About Masimo
Masimo, a Danaher company and a specialty diagnostics solutions innovator of pulse oximetry and other patient monitoring solutions, develops and produces a wide array of industry-leading monitoring technologies, including innovative measurements, sensors, patient monitors, and automation and connectivity solutions. Our mission is for our innovations to empower clinicians to transform patient care. Masimo SET® Measure-through Motion and Low Perfusion™ pulse oximetry, introduced in 1995, has been shown to outperform other pulse oximetry technologies in over 100 independent and objective studies, which can be found at www.masimo.com/evidence/featured-studies/feature. Masimo SET® is estimated to be used on more than 200 million patients around the world each year and is the primary pulse oximetry at all 10 top U.S. hospitals as ranked in the 2026 Newsweek World's Best Hospitals listing. Additional information about Masimo and its products may be found at www.masimo.com.
About Danaher
Danaher is a leading global life sciences and diagnostics innovator, committed to advancing the power of science and technology to improve human health. Through our connected ecosystem of industry-leading businesses, we work side by side with customers to solve many of their most complex scientific and clinical challenges—accelerating the moment scientific discovery becomes human impact. Powered by the Danaher Business System, our advanced science and technology and proven ability to innovate help enable faster, more accurate diagnoses and reduce the time, cost, and risk required to discover, develop, and deliver life-changing therapies. Through continuous improvement and operational excellence, our approximately 60,000 associates worldwide are focused on delivering lasting impact and improving quality of life around the world, while building a healthier, more sustainable tomorrow. That's Innovation at the speed of life. Explore more at www.danaher.com.
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Danaher, Diagnostics
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SOURCE Masimo Corporation
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