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Masimo Announces CE Mark of iSpO2(TM) Rx Pulse Oximeter for Mobile Devices

IRVINE, CA -- (Marketwired) -- 05/29/14 -- Masimo (NASDAQ: MASI) today announced that the iSpO2 ™ Rx Pulse Oximeter for Android™ and iOS devices has received CE Mark clearance for medical use in select countries, offering clinicians the power of Masimo SET® Measure-through Motion and Low Perfusion™ Pulse Oximetry on their smart phones and tablets.

iSpO2 Rx, available outside the U.S., provides accurate spot-check and short-term assessment of oxygen saturation (SpO2), pulse rate (PR), and perfusion index (PI). iSpO2 Rx is ideal for:

EMS, clinicians

  • Emergency clinicians who want the convenience and availability of pulse oximetry at times when other Masimo handheld oximetry solutions may not be available.

Traveling respiratory therapists and physicians

  • For those on the go who require convenient and portable solutions.

COPD patients

  • Patients under the care of a physician for chronic obstructive pulmonary diseases (COPD) such as emphysema, chronic bronchitis, and bronchiectasis, may benefit from the use of a pulse oximeter for spot checks.

Asthmatics

  • Patients under the care of a physician may use pulse oximetry to assess the severity of their asthma attack to help determine if a doctor or emergency room visit is warranted.

Compact and intuitive operation with a familiar touch-screen interface, iSpO2 Rx comes with an integrated finger pulse oximetry sensor or an optional M-LNCS ™ connector, which allows the iSpO2 Rx to be used with more than 20 Masimo SET® pulse oximetry sensors. iSpO2 Rx utilizes the same Masimo SET® Measure-through Motion and Low Perfusion™ pulse oximetry technology proven by more than 100 independent and objective studies and used on more than 100 million patients a year in leading hospitals worldwide, including eight of the top 10 on the U.S. News & World Report Best Hospitals Honor Roll (2013-2014). Masimo SET® pulse oximetry has been shown to help clinicians reduce ventilator weaning time and arterial blood gas measurements in the ICU,(1) and save lives and costs while reducing rapid response activations and ICU transfers on the general floor.(2)

iSpO2 Rx for select Android devices and iPad, iPhone, and iPod touch, also features a downloadable and upgradeable iSpO2 Rx App, ensuring clinicians have the latest mobile medical technologies at their fingertips at all times. iSpO2 Rx, with real-time display of pleth waveform with signal IQ for low measurement confidence, can store and email up to 12 hours of measurement history in a global standard .CSV file format. iSpO2 Rx with the M-LNCS connector is compatible with Masimo adhesive and reusable sensors for pediatric and adult use.

Available for purchase outside the U.S.

Android is a trademark of Google Inc. iPad, iPhone, and iPod touch are trademarks of Apple Inc., registered in the U.S. and other countries.

(1) Durbin, et al. Critical Care Medicine. 2002 Aug.;30(8): 1735 to 1740.
(2) Taenzer, Andreas H.; Pyke, Joshua B.; McGrath, Susan P.; Blike, George T. "Impact of Pulse Oximetry Surveillance on Rescue Events and Intensive Care Unit Transfers: A Before-and-After Concurrence Study." Anesthesiology, February 2010, Vol. 112, Issue 2.

About Masimo
Masimo (NASDAQ: MASI) is the global leader in innovative noninvasive 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 have shown that Masimo SET® outperforms other pulse oximetry technologies, even under the most challenging clinical conditions, including patient motion and low peripheral perfusion. In 2005, Masimo introduced rainbow Pulse CO-Oximetry technology, allowing noninvasive and continuous monitoring of blood constituents that previously could only be measured invasively, including total hemoglobin (SpHb®), oxygen content (SpOC™), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), and Pleth Variability Index (PVI®), in addition to SpO2, pulse rate, and perfusion index (PI). Additional information about Masimo and its products may be found at www.masimo.com.

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 related to the iSpO2 Rx, including our belief in the breakthrough ability of Masimo SET® pulse oximetry to measure-through motion and low perfusion; as well as other factors discussed in the "Risk Factors" section of our most recent reports filed with the Securities and Exchange Commission ("SEC"), which may be obtained for free at the SEC's website at www.sec.gov. 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 statements or the "Risk Factors" contained in our most recent reports filed with the SEC, whether as a result of new information, future events or otherwise, except as may be required under the applicable securities laws.

Masimo, SET, Signal Extraction Technology, Improving Patient Outcome and Reducing Cost of Care... by Taking Noninvasive Monitoring to New Sites and Applications, rainbow, SpHb, SpOC, SpCO, SpMet, PVI are trademarks or registered trademarks of Masimo Corporation

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