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Masimo Receives FDA Clearance for New Rainbow(R) Resposable(TM) Sensor System

IRVINE, Calif., July 21 /PRNewswire-FirstCall/ -- Masimo (Nasdaq: MASI), the inventor of Pulse CO-Oximetry(TM) and Measure-Through Motion and Low-Perfusion pulse oximetry, today announced the FDA 510(k) clearance of its new Masimo Rainbow Resposable(TM) Sensor System, a revolutionary new sensor system that offers the performance and comfort of a single-use adhesive disposable sensor with the cost-effectiveness and environmentally-green advantages of a reusable sensor. The new sensor system provides continuous and noninvasive measurements of hemoglobin (SpHb(TM)), oxygen content (SpOC(TM)), PVI(TM) for fluid responsiveness, and methemoglobin (SpMet((R))), in addition to oxygen saturation (SpO2), perfusion index, and pulse rate - at savings of about 50% compared to the existing single patient use adhesive Rainbow sensor.


The Rainbow Resposable Sensor System combines the best features of Masimo LNOP((R)), LNCS((R)), and Rainbow((R)) sensors into an innovative two-piece design that includes a reusable sensor - enabling the portion that connects to the patient cable to be used on multiple patients - while the adhesive disposable sensor that attaches directly to the patient's finger is used on only one patient. This dramatically minimizes waste, enabling hospitals to reduce their costs safely, and effectively fulfill their 'green' initiatives.

The reusable portion of the two-piece system provides multi-patient use for cost-effectiveness, while the flexible cable design maximizes patient comfort, and enables easy, one-step cleaning. The snap-in-place connector design allows easy connection and reconnection to the same patient - and reuse on the next patient. The single-use disposable portion of system features an adhesive that keeps emitter and detector positions stable against the skin to assure the best in Masimo SET and Rainbow SET measurement performance. The design maximizes fit and comfort for the patient, while the protective covering minimizes contact with patient to reduce cross contamination risk.

"We have tried the Masimo Rainbow Resposable System and found that these sensors provided us with all of the benefits and superior performance of Masimo's continuous and noninvasive Rainbow measurements, including noninvasive hemoglobin monitoring, along with the cleanliness and patient comforts of the standard single patient use sensor at a fraction of the cost and waste," stated Bertrand Debaene, M.D., Department of Anesthesia at the University Hospital Center in Poitiers, France.

"The Masimo Rainbow Resposable Sensor System is based on more than ten years of research and development stemming from the feedback of hundreds of clinicians who told us what they wanted most in a sensor - less waste and more value with superior performance," stated Masimo Founder and CEO, Joe E. Kiani. "We are happy that by combining the performance and patient comfort of a single-use adhesive sensor with the cost effectiveness of a reusable sensor, the Masimo Rainbow Resposable Sensor System also minimizes medical waste and its impact on the environment."

A Capgemini study released earlier this year showed that a typical 500-bed hospital incorporating Masimo Rainbow SET Pulse CO-Oximetry into its clinical standards and care pathways could generate nearly $500,000 in net annual cost savings and financial gains. With the Masimo Rainbow Resposable Sensor System, the potential savings to hospitals could increase to nearly $700,000 annually.

About Masimo

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

Forward Looking Statements

This press release includes forward-looking statements as defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, in connection with the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties, all of which are difficult to predict and many of which are beyond our control and could cause our actual results to differ materially and adversely from those expressed in our forward-looking statements as a result of various risk factors, including, but not limited to: risks related to our belief that the features, function and design of the Masimo Rainbow Resposable Sensor System will enable hospitals to reduce associated waste and costs, as well as other factors discussed in the "Risk Factors" section of our Quarterly Report on Form 10-Q for the fiscal quarter year ended April 4, 2009, filed with the Securities and Exchange Commission ("SEC") on May 6, 2009, which may be obtained for free at the SEC's website at Although we believe that the expectations reflected in our forward-looking statements are reasonable, we do not know whether our expectations will prove correct. All forward-looking statements included in this press release are expressly qualified in their entirety by the foregoing cautionary statements. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today's date. 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 fiscal quarter year ended April 4, 2009, filed with the Securities and Exchange Commission ("SEC") on May 6, 2009, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

    Dana Banks
    Masimo Corporation

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.

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