Press release
Masimo O3® Regional Oximetry Receives FDA Clearance for Expanded Indication of Its Unique Delta Hemoglobin Parameters
Now Available for Both Cerebral and Somatic Applications and for All Patient Populations, O3’s Delta Hemoglobin Parameters Offer Clinicians Additional
About this update from Masimo Corporation
[{"type":"text","content":"\nNow Available for Both Cerebral and Somatic Applications and for All Patient Populations, O3’s Delta Hemoglobin Parameters Offer Clinicians Additional Insight Into Changes in Tissue Oxygen Saturation\n\n\n IRVINE, Calif.--(BUSINESS WIRE)--\nMasimo (NASDAQ: MASI) today announced the FDA 510(k) clearance of expanded indications for the delta hemoglobin parameters provided with O3® Regional Oximetry. The parameters (ΔcHb, ΔHHb, and ΔO2Hb) display relative changes in hemoglobin that can help clinicians identify the underlying mechanisms responsible for changes in tissue oxygen saturation. With this latest clearance, this capability is now available for use in both cerebral and somatic applications as well as for all patient populations, including pediatric and neonatal patients.\n\nThis press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20250819705315/en/Masimo Root® with SedLine® Brain Function Monitoring and O3® Regional Oximetry with Delta Hemoglobin Parameters\nO3, available on Masimo’s Root® patient monitoring and connectivity platform, uses near-infrared spectroscopy (NIRS) to monitor and display continuous regional oxygen saturation values (rSO2) in the tissue of interest. rSO2 reflects the balance between oxygen delivery and metabolic demands in the organ being monitored. However, rSO2 alone may not always indicate the reason for any imbalance. With the addition of delta hemoglobin parameters, clinicians can gain the insight needed to better understand why a patient’s rSO2 is changing by monitoring relative changes in the underlying components used to determine it: total hemoglobin (cHb), deoxygenated hemoglobin (HHb), and oxygenated hemoglobin (O2Hb). These additional data support more informed clinical assessment of the appropriate intervention, ultimately helping drive improvements in the patient’s care.\n\n\nEach of these parameters can provide valuable additional context for helping clinicians assess a variety of physiological conditions. For example, venous congestion, a slowing or pooling of blood that has been associated with negative outcomes in a variety of scenarios, such as the failure of reconstructive flaps, has been found to increase total hemoglobin (cHb) in tissue.1\n\n\nThe use of the O3 delta hemoglobin parameters has also been successfully incorporated ...