Masimo (Nasdaq: MASI) announced today that it received FDA 510(k) clearance for expanded indications for its O3 regional oximetry technology.
The expanded indication covers the delta hemoglobin parameters provided with the oximetry platform. 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.
Masimo says the latest clearance makes this capability available for use in both cerebral and somatic applications. It also covers all patient populations, including pediatric and neonatal patients. O3 originally received FDA clearance in 2020.
The company offers O3 on its Root patient monitoring and connectivity platform. It uses near-infrared spectroscopy (NIRS) to monitor and display continuous regional oxygen saturation values (rSO2) in the tissue of interest.
According to Masimo, rSO2 reflects the balance between oxygen delivery and metabolic demands in the organ being monitored. However, it may not always indicate the reason for any imbalance. Adding delta hemoglobin parameters offers more insights to these changing levels by monitoring the underlying components used to determine rSO2. Masimo says each of the parameters can provide valuable additional context for assessing a variety of physiological conditions.
O3 also combines with SedLine brain functioning monitoring on Root, Masimo said. This means the company offers what it labels the only brain health solution on the market to provide comprehensive data about the bilateral brain on a single platform.
Masimo SVP of Global Clinical Affairs & Solutions, Dr. Basil Matta, said:
“Ensuring vital organs and tissues are receiving enough oxygen to meet their metabolic needs is the cornerstone of optimal anesthesia and critical care. Masimo SedLine provides a measure of brain activity and thus indirectly oxygen demand. O3 provides an indication of the balance between vital organ oxygen delivery, by tracking relative changes in oxygenated hemoglobin (O2Hb), and demand, by tracking the changes in deoxygenated hemoglobin (HHb). By using SedLine and O3 together, the clinician can investigate why this balance may have changed, as indicated by concomitant changes in delta hemoglobin parameters – and take advantage of this complementary information, as part of their overall clinical assessment, in initiating the appropriate intervention to restore the balance of oxygen delivery to demand baseline. Masimo Root with O3 and SedLine is a true brain health platform and provides a truly multimodal view of the brain.”
