IRVINE, Calif., August 25, 2026
Masimo, a Danaher company focused on specialty diagnostics and patient monitoring technologies, announced that the U.S. Food and Drug Administration (FDA) has granted 510(k) clearance for the Masimo Root® with LiDCO® hemodynamic monitoring solution, including the Masimo LiDCO sensor. The cleared solution is designed to provide clinicians with continuous monitoring and trending of oxygen delivery (DO₂) by combining cardiac output, arterial oxygen saturation and noninvasive hemoglobin measurements. The development is intended to give clinicians a more integrated view of how effectively oxygen is being transported to tissues, particularly during major surgery and other periods of physiological stress.
Root With LiDCO Enables Continuous Oxygen Delivery Assessment
The newly cleared solution brings together three monitoring capabilities within Masimo’s patient-monitoring ecosystem: LiDCO hemodynamic monitoring, Masimo SpHb® noninvasive hemoglobin, and Masimo SET® pulse oximetry. Together, these measurements support continuous assessment of oxygen delivery, which reflects both the amount of blood reaching tissues and the oxygen content carried within that blood. Historically, continuous visibility into DO₂ has been limited because hemoglobin measurements typically depend on intermittent laboratory testing. By combining these measurements, Masimo aims to provide clinicians with continuous beat-to-beat visibility into changes in oxygen delivery, rather than relying on individual laboratory measurements or isolated hemodynamic parameters.
Continuous DO₂ Monitoring Targets a Key Clinical Gap
Oxygen delivery is an important physiological parameter during periods when patients face increased metabolic or circulatory stress. Masimo highlighted the concept of oxygen debt, which represents the cumulative difference between the oxygen required by tissues and the oxygen being delivered. If inadequate oxygen delivery persists, oxygen debt may contribute to serious complications, including organ dysfunction, sepsis and death. The company also pointed to previous clinical research supporting oxygen delivery as an actionable physiological target in high-risk surgical patients. By enabling continuous monitoring of DO₂, the Root with LiDCO solution is designed to help clinicians identify changes in oxygen transport as they occur and potentially support more informed management of patients undergoing complex procedures.
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Masimo Expands Integrated Patient Monitoring Portfolio
The FDA clearance expands the capabilities of Masimo’s monitoring portfolio by bringing cardiac output, hemoglobin and oxygen saturation together to provide a continuous measure of oxygen delivery. Rather than evaluating blood pressure, cardiac output or oxygen saturation independently, the technology is designed to provide a more comprehensive assessment of oxygen transport to tissues. Masimo said the solution could be particularly relevant during high-risk surgery and critical care, where rapid changes in cardiovascular status and oxygen requirements can have significant clinical consequences. The clearance further advances the company’s strategy of integrating multiple physiological measurements into connected monitoring solutions that provide clinicians with continuous, actionable patient data during periods of physiological stress.
Source: Masimo, press relese
