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Masimo Announces FDA Clearance of Root (TM) Patient Monitoring Platform With Capnography, IRIS(TM) Standalone Device Connectivity, and MOC-9(TM) Third-Party Measurement Expansion

IRVINE, CA -- (Marketwired) -- 06/30/14 -- Masimo (NASDAQ: MASI) today announced FDA 510(k) clearance of the Root™ patient monitoring and connectivity platform that is destined to transform patient care throughout the hospital. High-impact innovations in Root that are now available in the U.S. include:

  • Iris™ - Built-in connectivity gateway through Iris™ for standalone devices such as IV pumps, ventilators, hospital beds, and other patient monitors
  • MOC-9™ - Flexible measurement expansion through Masimo Open Connect™ (MOC-9™) with MOC-9 modules from Masimo or third-party measurement by other companies to expand the platform's measurements and capabilities. New MOC-9 modules will require new 510(k) clearances
  • Capnography - ISA™ CO2 sidestream module featuring fast warm up time and the innovative and cost-effective Nomoline™ sampling line
  • Wireless functionality - Capable of transmitting information through Bluetooth and Wi-Fi.

Masimo's breakthrough rainbow® and SET® measurements from the Radical-7® handheld monitor that docks into Root enable instant interpretation with a 10-inch high visibility, intuitive navigation touchscreen display. In addition, the previously released SedLine brain function monitoring MOC-9 module for Root advances brain function monitoring to improve the care of patients under anesthesia or sedation.

Built-in Connectivity Gateway through Iris™
Despite medical technology advances, the lack of device communication and integration creates risks to patient safety in hospitals around the world. Without device interoperability, critical patient information can go unnoticed -- leaving busy clinicians in the dark and vulnerable patients in danger. Existing approaches for device interoperability require separate hardware, software, and/or network infrastructure, which can clutter the patient room, increase complexity, burden IT management, and increase costs.

To address these challenges, each Root can be used as a connectivity gateway to connect multiple standalone devices -- such as IV pumps, ventilators, hospital beds, and other patient monitors -- when used as part of the optional Iris connectivity package in Masimo Patient SafetyNet™. Iris allows standalone device information to be remotely viewed with Patient SafetyNet, transmitted through notification systems or sent to electronic health record (EHR) systems to facilitate better patient care. Iris connectivity enables standalone devices to leveage existing network infrastructure and reduce costs while enhancing clinical workflows and decision support to improve patient safety, whether the clinician is at the bedside, down the hall, or across the globe.

ISA Capnography MOC-9 Module
The ISA CO2 module for Root provides ETCO2 and respiratory rate measurements with crisp waveforms and fast warm up time. In addition, customers can use the Nomoline™ "No Moisture" fluid protection sample line, which is specially designed for low-flow applications and excellent response time -- making gas measurement possible even at high respiratory rates. Nomoline supports single-patient use in high humidity environments or multi-patient use in lower-humidity environments to reduce disposable costs, and can be used for all types of patients from infants to adults.

MOC-9: Designed for Third-Party Development of Expanded Measurements
Root is also designed to allow other companies to expand the platform's measurements with their own measurements through MOC-9 by following Masimo's established development and validation process.

Market barriers and development costs often keep small, innovative companies from delivering their products to clinicians and patients who need them most. With Root's accessible patient monitoring platform, Masimo is offering an open invitation to other companies to develop and commercialize their innovations through Masimo's ever-expanding customer base.

Companies interested in developing a MOC-9 measurement can request more information online at:
http://www.masimo.com/root/index.htm

"With the new FDA clearance for Root, Masimo is eager to help U.S. clinicians usher in a new era of patient care and improved patient safety with a platform that should measurably improve the performance and cost curve," said Joe Kiani, founder and CEO of Masimo. "Root can be a hub at the bedside, enable Masimo's breakthrough noninvasive measurements to be used by experts and novices with the trend and analog views, take advantage of a rich set of additional measurements, and allow other companies a robust platform on which to develop other innovative measurements via MOC-9."

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 help clinicians 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 required invasive procedures; total hemoglobin (SpHb®), oxygen content (SpOC™), carboxyhemoglobin (SpCO®), methemoglobin (SpMet®), PVI®, and perfusion index (PI), in addition to measure-through motion SpO2, and pulse rate. In 2008, Masimo introduced Patient SafetyNet™, a remote monitoring and wireless clinician notification system designed to help hospitals avoid preventable deaths and injuries associated with failure to rescue events. In 2009, Masimo introduced rainbow® Acoustic Monitoring™, the first-ever commercially available noninvasive and continuous monitoring of acoustic respiration rate (RRa™). Masimo SET® and Masimo rainbow® technologies also can be found in over 100 multiparameter patient monitors from over 50 medical device manufacturers around the world. Founded in 1989, Masimo has the mission of "Improving Patient Outcome 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 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, including, but not limited to: risks related to our assumptions regarding the repeatability of clinical results; risks related to our assumptions regarding timing of regulatory clearances and commercial availability in other countries; risks related to our assumptions that Root will provide a connectivity platform for any standalone device; and risks related to our assumption that Root will support/enable any third-party development of new measurements, technologies, product through MOC-9; 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 forward-looking 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

Press Note: The included product photos illustrating various features and display screens on Root™ are available for media use and publication only.

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