The leading pulse oximetry system now includes first of its kind detection for atrial fibrillation together with previously cleared AI powered identification of opioid induced respiratory depression. These tools work in tandem to deliver earlier clinical information to care teams.

Masimo, a Danaher company and innovator in pulse oximetry along with other patient monitoring tools, announced FDA 510(k) clearance for AFib capability on Radius VSM. Combined with its already cleared AI enabled OIRD detection feature, smartSET extends pulse oximetry past single readings by applying advanced pattern recognition and AI signal analysis to help clinicians spot physiological shifts tied to key clinical events.

Building on the established Masimo Signal Extraction Technology pulse oximetry and more than 35 years of signal processing advances, smartSET marks the next step in SET evolution. It moves continuous monitoring from dependable measurement toward useful clinical insight. The AFib and AI enabled OIRD features assist clinicians in spotting rhythms that suggest AFib as well as physiological patterns linked to OIRD to enable earlier assessment and action.

When a patient worsens on a general care floor, respiratory issues and heart rhythm problems often develop without notice between standard checks, said Dr. Basil Matta, Chief Medical Officer at Masimo. By adding AI driven pattern recognition into the pulse oximetry process, smartSET helps clinicians notice small physiological changes sooner. It closes the gap between spot checks and gives care teams useful information when time matters.

For more than three decades Masimo has broadened what clinicians can expect from pulse oximetry, said Tim Benner, President of Masimo. With smartSET we bring intelligent sensing and AI enabled detection to the bedside, using our signal processing knowledge to convert continuous monitoring data into practical clinical insight. Adding AFib monitoring to smartSET along with AI enabled OIRD detection marks a significant step forward to give clinicians earlier visibility into serious patient risks before symptoms worsen. We plan to keep expanding the smartSET platform to meet other important clinical needs. This is how we drive innovation by focusing on the information clinicians require to care for patients.

Recognizing Rhythms Suggestive of AFib

AFib affects more than 10 percent of patients over age 65 and often goes undiagnosed, raising the long term risk of stroke. The smartSET PPG AFib feature continuously reviews pulse waveform data to identify rhythms suggestive of AFib, helping clinicians decide when extra electrocardiogram or telemetry review may be needed. The feature offers an indication for further clinical review and does not replace ECG confirmation of AFib.

In clinical validation testing the AFib feature showed sensitivity and specificity of 97 percent and 100 percent respectively. The study covered groups with and without AFib, including some with other arrhythmias. It compared the PPG AFib feature classifications against those from three clinicians who reviewed the matching ECG strips as the reference standard for an AFib classification.

Helping Clinicians Recognize and Respond to OIRD

One in 10 surgical patients who receive opioids face an opioid related adverse event, while 85 percent of postoperative OIRD events happen within the first 24 hours after surgery. Continuous monitoring addresses the gaps between routine spot checks, yet spotting OIRD still relies on noticing concerning trends in the data. The smartSET OIRD feature continuously reviews oxygen saturation, pulse rate, and perfusion index in real time to evaluate opioid overdose risk. By identifying patterns tied to OIRD the system issues escalating alerts on Radius VSM and aims to give clinicians added confidence.

From Signal Processing to Clinical Insight

With AFib and OIRD features available inside a standard pulse oximetry workflow, smartSET broadens the clinical information clinicians can gain from continuous pulse oximetry monitoring by moving past single measurements to automated detection and helping clinicians recognize 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 over a monitoring period to support 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 on the company evidence site. 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 on the company website.

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 is Innovation at the speed of life. Explore more on the company website.

Media Contact:

Ilke Limoncu
Vice President, Communications
Danaher, Diagnostics
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SOURCE Masimo Corporation