Powered by smartSET™, the Pattern Recognition Capability Analyzes Continuous Patient Data to Provide Clinicians With Earlier Insight Into Opioid-Related Respiratory Risk

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.

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Opioid-Induced Respiratory Depression Detection with Masimo smartSET™ and Radius VSM®

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.

Forward-Looking Statements and Other Information

Statements in this release that are not strictly historical, including the statements regarding extending smartSET’s transformative impact across care environments, and any other statements regarding events or developments that we believe or anticipate will or may occur in the future are "forward-looking" statements within the meaning of the federal securities laws. There are a number of important factors that could cause Danaher Corporation’s and its subsidiaries’ actual results, developments and business decisions to differ materially from those suggested or indicated by such forward-looking statements and you should not place undue reliance on any such forward-looking statements. These factors include, among other things: the impact of the tariffs and related actions implemented by the U.S. and other countries, the impact of our debt obligations (including debt we have incurred to finance the acquisition of Masimo Corporation) on our operations and liquidity, deterioration of or instability in the global economy, the markets we serve and the financial markets, uncertainties with respect to the development, deployment, and use of artificial intelligence in our business and products, the impact of global health crises, uncertainties relating to national laws or policies, including laws or policies to protect or promote domestic interests and/or address foreign competition, our ability to successfully identify and consummate appropriate acquisitions and strategic investments, our ability to integrate the businesses we acquire and achieve the anticipated growth, synergies and other benefits of such acquisitions, contingent liabilities and other risks relating to acquisitions, investments, strategic relationships and divestitures (in each case, including with respect to our recent acquisition of Masimo Corporation), including tax-related and other contingent liabilities relating to past and future IPOs, split-offs or spin-offs, contractions or growth rates and cyclicality of markets we serve, competition, our ability to develop and successfully market new products and technologies and expand into new markets, the potential for improper conduct by our employees, agents or business partners, our compliance with applicable laws and regulations (including rules relating to off-label marketing and other regulations relating to medical devices and the health care industry), the results of our clinical trials and perceptions thereof, our ability to effectively address cost reductions and other changes in the health care industry, security breaches or other disruptions of our information technology systems or violations of data privacy laws, risks relating to potential impairment of goodwill and other intangible assets, currency exchange rates, tax audits and changes in our tax rate and income tax liabilities, changes in tax laws applicable to multinational companies, litigation, regulatory proceedings and other contingent liabilities including intellectual property and environmental, health and safety matters, the rights of the United States government with respect to our production capacity in times of national emergency or with respect to intellectual property/production capacity developed using government funding, risks relating to product, service or software defects, product liability and recalls, risks relating to our manufacturing operations, the impact of climate change, legal or regulatory measures to address climate change and other sustainability topics and our ability to address regulatory requirements or stakeholder expectations relating to climate change and other sustainability topics, risks relating to fluctuations in the cost and availability of the supplies we use (including commodities) and labor we need for our operations, our relationships with and the performance of our channel partners, uncertainties relating to collaboration arrangements with third-parties, the impact of deregulation on demand for our products and services, labor matters and our ability to recruit, retain and motivate talented employees, U.S. and non-U.S. economic, political, geopolitical, legal, compliance, social and business factors (including the impact of elections, regulatory and policy changes or uncertainty, government shutdowns and military conflicts such as the conflict in the Middle East), disruptions and other impacts relating to man-made and natural disasters, inflation and the impact of our By-law exclusive forum provisions. Additional information regarding the factors that may cause actual results to differ materially from these forward-looking statements is available in Danaher Corporation’s SEC filings, including Danaher Corporation’s 2025 Annual Report on Form 10-K and Quarterly Report on Form 10-Q for the first quarter of 2026. These forward-looking statements speak only as of the date of this release and except to the extent required by applicable law, Danaher Corporation does not assume any obligation to update or revise any forward-looking statement, whether as a result of new information, future events and developments or otherwise.

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Media Contact:

Christine McCullough

christine.mccullough@masimo.com

Masimo Receives FDA 510(k) Clearance for AI-Enabled Opioid-Induced Respiratory Depression (OIRD) Detection on Radius VSM® to Help Identify Respiratory Risk Sooner