Masimo Receives FDA Clearance for Noninvasive Total Hemoglobin Adhesive
IRVINE, Calif., Sept. 15 /PRNewswire-FirstCall/ -- Masimo (Nasdaq: MASI), the inventor of Pulse CO-Oximetry and Measure-Through-Motion-and-Low-Perfusion pulse oximetry, today announced limited release of its noninvasive and continuous hemoglobin (SpHb(TM)) and oxygen content (SpOC(TM)) monitors, Radical-7 and Rad-87. Masimo also announced the FDA 510(k) clearance of its latest Rainbow family of adhesive sensors capable of noninvasively measuring total hemoglobin and oxygen content, along with oxygen saturation (SpO2), pulse rate, pleth variability index (PVI), and methemoglobin (SpMet(R)), for use with Masimo Rainbow SET-enabled devices.
The limited release of Masimo Radical-7 and Rad-87 Pulse CO-Oximeters with noninvasive and continuous total hemoglobin technology will allow select hospitals around the world to be the first to pioneer a breakthrough technology that may make it safer, faster, and easier for healthcare professionals to measure hemoglobin -- without removing a drop of blood. Hospitals purchasing noninvasive hemoglobin devices and selected for the limited product release will work closely with Masimo to implement the technology in their facilities and provide data on its impact on patient care.
"Current methods for measuring total hemoglobin are invasive and only offer delayed and intermittent results," stated Joe E. Kiani, Masimo Chairman and CEO. "We look forward to working closely with the first customers of our noninvasive hemoglobin monitoring technology to enable earlier and better clinical decisions, improve patient safety, and decrease costs."
Today, hemoglobin is one of the most commonly-performed clinical
laboratory tests with more than 400 million performed annually in the U.S.
alone. A low hemoglobin level is called anemia, a pervasive blood disorder
that according to the World Health Organizat
|SOURCE Masimo Corporation|
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