Powered by smartSET™, the Pattern Recognition Capability Analyzes Continuous Patient Data to Provide Clinicians With Earlier Insight Into Opioid-Related Respiratory Risk
IRVINE, Calif.–(BUSINESS WIRE)–#Masimo—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 an opioid-induced respiratory depression detection capability integrated into the Radius VSM® wearable continuous patient monitor. Enabled by Masimo’s next-generation smartSET™ pulse oximetry sensor platform, the new feature uses advanced pattern recognition that analyzes continuous physiologic data to help clinicians identify early signs of respiratory compromise in hospital patients receiving opioid therapy.
This clearance represents the first implementation of Masimo’s OIRD detection capability in a hospital monitoring solution. By combining the trusted signal quality of best-in-class Masimo SET® with AI-enabled analysis, smartSET features like OIRD detection are expanding the role of pulse oximetry from monitoring patient status to surfacing actionable insights. Translating continuous data into earlier clinical awareness supports faster, more informed decisions when time matters most, such as when a patient’s condition is rapidly worsening. To accelerate the potential impact of such technology on how patient care is delivered throughout the hospital, Masimo is developing additional pattern-recognition algorithms for the smartSET platform.
“Opioid-Induced Respiratory Depression remains a critical patient-safety concern,” said Dr. Basil Matta, Chief Medical Officer at Masimo. “With OIRD detection, Masimo is bringing advanced pattern recognition to continuous, wearable monitoring to help clinicians identify earlier changes in a patient’s respiratory status that may not be apparent through traditional approaches. This capability reflects our ongoing focus on working closely with clinicians to address complex patient-safety challenges with meaningful innovation. OIRD detection on Radius VSM will help expand continuous monitoring from simple measurement to meaningful insight, supporting safer care throughout the hospital.”
Building on industry-leading RD SET® sensor technology, smartSET is engineered to unlock the value of continuous parameter insights by analyzing complex physiological patterns and relationships rather than relying on individual parameters alone. Its design also allows for future integration into additional hospital monitoring solutions, extending its transformative impact across care environments as part of Masimo’s broader connected ecosystem.
Radius VSM is a wearable, tetherless, modular vital signs monitor designed to support continuous assessment of patient status throughout the hospital, with the ability to tailor monitoring to meet each patient’s needs. The addition of smartSET-powered analysis and OIRD detection to Radius VSM expands the platform’s ability to assist clinicians in spotting changes in patient condition and helps bring advanced physiological insight to more care areas. The OIRD feature includes visual alarms, which alert clinicians to changes in a patient’s condition and escalate as OIRD risk increases. The alarms are presented on the device’s display and can be relayed to remote and centralized monitoring stations.
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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 accelerating 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 their most complex scientific and clinical challenges—helping move innovations from discovery to delivery faster for patients who depend on them. 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. Explore more at www.danaher.com.
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