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 Organization (WHO) affects two billion people worldwide and causes one million deaths a year. Anemia can be chronic or acute. Chronic anemia is characterized by consistently low hemoglobin levels that can be the result of a diet deficiency, or illness such as cancer. Acute anemia is characterized by a sudden drop in hemoglobin levels that can result from internal or external bleeding due to surgery or trauma.
Masimo noninvasive total hemoglobin (SpHb(TM)) and oxygen content (SpOC(TM)) are part of Masimo Rainbow SET Pulse CO-Oximetry, the first and only technology platform to noninvasively measure blood constituents and fluid responsiveness that previously required invasive procedures. In addition to hemoglobin and oxygen content, Rainbow measurements include: carboxyhemoglobin (SpCO(R)), methemoglobin (SpMet(R)) and Pleth Variability Index (PVI) -- in addition to the 'Gold Standard' measure-through-motion-and-low-perfusion performance of Masimo SET Oxygen Saturation (SpO2), Pulse Rate (PR) and Perfusion Index (PI).
Masimo (Nasdaq: MASI) develops innovative monitoring technologies that significantly improve patient care-helping solve "unsolvable" problems. In 1995, the company debuted Measure-Through-Motion-and-Low-Perfusion pulse oximetry, known as Masimo SET, which virtually eliminated false alarms and increased pulse oximetry's ability to detect life-threatening events. More than 100 independent and objective studies demonstrate Masimo SET provides the most reliable SpO2 and pulse rate measurements even under the most challenging clinical conditions, including patient motion and low peripheral perfusion. In 2005, Masimo introduced Masimo Rainbow SET Pulse CO-Oximetry, a breakthrough noninvasive blood constituent monitoring platform that can measure many blood constituents that previously required invasive procedures. Masimo Rainbow SET continuously and noninvasively measures total hemoglobin (SpHb(TM)), oxygen content (SpOC(TM)), carboxyhemoglobin (SpCO(R)), methemoglobin (SpMet(R)), and PVI(TM), in addition to oxyhemoglobin (SpO2), pulse rate (PR), and perfusion index (PI), allowing early detection and treatment of potentially life-threatening conditions. Founded in 1989, Masimo has the mission of "Improving Patient Outcomes and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications." Additional information about Masimo and its products may be found at http://www.masimo.com.
Forward Looking Statements
This press release may include forward-looking statements. These
forward-looking statements are based on current expectations about future
events affecting us and are subject to uncertainties and factors, all of
which are difficult to predict and many of which are beyond our control,
including: risks related to our assumption that Masimo noninvasive and
continuous total hemoglobin technology will provide faster, easier and
safer means for measuring total hemoglobin and will lead to additional
device sales, and risks related to our assumption that noninvasive total
hemoglobin will be available in the first quarter of 2009, as well as other
factors discussed in the "Risk Factors" section of our quarterly report on
Form 10-Q for the quarter ended June 28, 2008, filed with the Securities
and Exchange Commission on August 5, 2008. Although we believe that the
expectations reflected in our forward-looking statements are reasonable, we
do not know whether our expectations will prove correct. You are cautioned
not to place undue reliance on these forward-looking statements, which
speak only as of the date hereof. We do not undertake any obligation to
update, amend or clarify these forward-looking statements or the risk
factors contained in our quarterly report on Form 10-Q for the quarter
ended June 28, 2008, whether as a result of new information, future events
or otherwise, except as may be required under the federal securities laws.
Masimo, SET, Signal Extraction Technology, Improving Outcomes and Reducing Cost of Care by Taking Noninvasive Monitoring to New Sites and Applications, Rainbow, SpHb, SpOC, SpCO, SpMet, PVI, Radical-7, Rad-87, Rad-57, Rad-9, Rad-8, Rad-5, Pulse CO-Oximetry and Pulse CO-Oximeter are trademarks or registered trademarks of Masimo Corporation.
|SOURCE Masimo Corporation|
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