News | February 25, 2008

Masimo Plans Continuous Noninvasive Total Hemoglobin Debut

February 26, 2008 - Masimo announced it would debut its technology for noninvasive and continuous total hemoglobin (SpHb) and oxygen content (SpOC) monitoring at the World Congress of Anesthesiology (WCA) in Cape Town, South Africa, March 3, 2008.
The advent of noninvasive total hemoglobin within the Masimo Rainbow SET platform will reportedly make hemoglobin testing more convenient and broadly available to medical personnel in both the acute and outpatient settings— the measurement is said to be instantaneous and pain-free. Prior to Masimo Rainbow SET, invasive and time-consuming lab tests to determine total hemoglobin levels provided delayed and intermittent data.
Masimo expects to make SpHb and SpOC shipments to select customers for clinical use in the second half of 2008, pending regulatory clearances. There is a 510(k) pending for SpHb and SpOC in the U.S.
"From its application as a noninvasive tool for universal hemoglobin screening at routine health check-ups to the management of blood loss and blood replacement in patients experiencing acute blood loss, or those undergoing surgery— these new measurements could prove to be indispensable in a wide variety of healthcare settings," Martin Allard, M.B.Ch.B, FRC, Professor and Director of Research, Department of Anesthesiology, Loma Linda University, stated.
The Masimo Rainbow SET technology platform is designed to provide clinicians with access to real-time trending and tracking of a patient's total hemoglobin status enabling them to quickly identify conditions of anemia, or blood loss. When patients undergo blood transfusions, the company says clinicians will be able to use Masimo Rainbow SET SpHb to titrate blood and maintain hemoglobin levels within acceptable ranges. Additionally, continuous monitoring of hemoglobin levels may provide clinicians with an early warning of possible internal hemorrhaging in the emergency department, trauma and post-op settings. Because blood and hemoglobin restoration must be carefully titrated to targeted levels to avoid potentially serious morbidities, Masimo Rainbow SET SpHb provides instant feedback that the proper levels are achieved, advancing patient safety and accelerating recovery.
On July 30, 2007, The Centers for Medicare and Medicaid Services released their final National Coverage Determination (NCD) restricting coverage for the treatment of anemia, specifically Erythropoiesis Stimulating Agents (ESA) therapy, to when the hemoglobin level is less than 10g/dL. This ruling makes hemoglobin testing a prerequisite to coverage and possibly administration of ESA therapy in certain patients.
According to the company, a simple upgrade to most Masimo Radical pulse oximeters is all that will be necessary to transform an existing monitor to Masimo Rainbow SET performance - enabling integration of noninvasive total hemoglobin monitoring into any clinical setting.
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