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

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

1. Shoemaker et al. Role of oxygen debt in the development of organ failure, sepsis, and death in high-risk surgical patients. Chest. 1992;102(1):208-215.
2. Woods et al. Reducing the risk of major elective surgery: randomized controlled trial of preoperative optimization of oxygen delivery. BMJ. 1999;318(7191):1099-1103.
3. Boyd et al. A randomized clinical trial of the effect of deliberate perioperative increase of oxygen delivery on mortality in high-risk surgical patients. JAMA. 1993;270(22):2699-2707.

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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Media Contact:

Christine McCullough
Masimo Head of Global Communications
[email protected] 

SOURCE Masimo Corporation