Masimo Receives FDA 510(k) Clearance for Root® with LiDCO® and the Masimo LiDCO Sensor to Provide Continuous Oxygen Delivery (DO₂)

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The Power of LiDCO Hemodynamic Monitoring, Noninvasive Hemoglobin (SpHb®), and Masimo SET® Pulse Oximetry Brings Continuous, Beat-to-Beat Assessment of Oxygen Delivery IRVINE, Calif., Aug. 25, 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 the Masimo Root® with LiDCO® hemodynamic monitoring solution, including the Masimo LiDCO sensor. This comprehensive solution provides the unique ability to continuously monitor and trend oxygen delivery (DO₂) that reflects changes in both cardiac output and arterial oxygen content. Oxygen delivery is the rate at which oxygen is transported from the lungs to the tissue that reflects both how much blood is delivered and how much oxygen is in the blood. Historically, DO₂ monitoring has been limited because hemoglobin was measured intermittently through periodic laboratory measurements, limiting visibility into changes in oxygen delivery. By combining continuous Masimo SpHb® noninvasive hemoglobin, Masimo SET® oxygen saturation, and cardiac output, Masimo can provide a more complete view of oxygen being delivered to the tissue. "Oxygen delivery is fundamental to understanding whether tissues are receiving the oxygen they need, particularly during major surgery and other periods of physiologic stress," said Dr. Basil Matta, Consultant in Critical Care, Affiliated Professor at the University of Cambridge and Chief Medical Officer at Masimo. "Historically, clinicians have lacked continuous visibility into DO₂ because hemoglobin measurements relied on intermittent laboratory testing. As a surrogate of oxygen delivery, clinicians rely on blood pressure and in more critically ill patients, cardiac output. However, although you need pressure to have flow, and you need flow to deliver oxygen, blood pressure and cardiac output in isolation do not guarantee adequate oxygen delivery. By bringing together LiDCO hemodynamic monitoring, noninvasive SpHb, and Masimo SET pulse oximetry, we can provide a continuous view of oxygen delivery and help clinicians better understand changes in a patient's oxygen supply as they occur."  The clinical importance of oxygen delivery has been studied extensively in high-risk surgical patients. Research has established DO₂ as an actionable physiologic target and described "oxygen debt" as the cumulative gap between the oxygen tissues need and the oxygen being delivered . If not corrected early, oxygen debt can progress to multi-organ failure, sepsis, and death. ¹ Clinical studies have also demonstrated the potential impact of DO₂-guided care. In a randomized controlled trial of 138 patients undergoing major elective surgery, preoperative optimization of oxygen delivery reduced mortality from 17% in the control group to 3% in the preoptimized group.² In another randomized trial of 107 high-risk surgical patients, deliberately increasing oxygen delivery to a target of greater than 600 mL/min/m² using dopexamine reduced 28-day mortality by 75% relative to standard perioperative care. ³ Continuous DO₂ monitoring expands the capabilities of Masimo's patient monitoring portfolio by unifying cardiac output, hemoglobin, and oxygen saturation into a single, continuous measure of oxygen delivery. By providing clinicians with the ability to monitor and trend changes in DO₂ over time, Masimo is helping provide a more integrated view of oxygen transport during periods of physiologic stress. The clearance reflects Masimo's continued focus, as part of Danaher, on translating innovative monitoring technologies into meaningful clinical impact, helping clinicians gain greater insight into patient status when it matters most. References 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 the potential impact and benefits of LiDCO , 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. Media Contact: Christine McCullough Masimo Head of Global Communications [email protected]   View original content to download multimedia: https://www.prnewswire.com/news-releases/masimo-receives-fda-510k-clearance-for-root-with-lidco-and-the-masimo-lidco-sensor-to-provide-continuous-oxygen-delivery-do-302858929.html

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