18:50 uur 22-06-2015

Masimo krijgt CE-markering voor pulse-oxymeter MightySat Rx

Masimo heeft vandaag aangekondigd dat zijn pulse-oxymeter voor op de vingertoppen MightySat Rx een CE-markering heeft gekregen en dientengevolge verkrijgbaar is in alle CE-landen. Het instrument voor klinisch gebruik biedt dezelfde technologie pulse-oxymetrie, de Masimo SET Measure-Through Motion and Low Perfusion-technologie, die wordt gebruikt in ’s werelds meest toonaangevende ziekenhuizen.

Bluetooth-versies van MightySat Rx bieden artsen de mogelijkheid twaalf uur aan patiëntmetingen na te lopen op een smartmobiel. Hij of zij kan deze gegevens vervolgens delen via standaard CSV-bestanden of via de Health-applicatie van Apple.

 

Masimo Receives CE Mark for MightySat Rx Pulse Oximeter

World’s First Wireless Fingertip Pulse Oximeter with Masimo SET Technology Enables Clinicians to Track and Trend Measurements through Smart Mobile Devices

NEUCHÂTEL, Switzerland – (Business Wire)

Masimo (NASDAQ: MASI) today announced the CE Mark and full market release of MightySat™ Rx fingertip pulse oximeter for clinical use in CE countries, offering the same Masimo SET® Measure-Through Motion and Low Perfusion™ pulse oximetry technology used in the world’s leading hospitals.

This Smart News Release features multimedia. View the full release here:http://www.businesswire.com/news/home/20150622005569/en/

MightySat™ Rx fingertip pulse oximeter provides oxygen saturation (SpO2), pulse rate (PR), Perfusion ... MightySat™ Rx fingertip pulse oximeter provides oxygen saturation (SpO2), pulse rate (PR), Perfusion Index (PI), and Pleth Variability Index (PVI®). (Photo: Business Wire)

Bluetooth®-enabled versions of MightySat Rx allow clinicians to track and trend up to 12 hours of patient measurements on smart mobile devices, and to share that data via standard CSV files as well as transfer to Apple’s Health app.

MightySat Rx enables accurate noninvasive spot-checking of oxygen saturation (SpO2) and pulse rate (PR) for adult and paediatric patients even during motion and low perfusion. MightySat Rx measures and displays Perfusion Index (PI), which reflects the strength of the pulsatile signal. MightySat can also measure and display Pleth Variability Index (PVI®), a measure of the dynamic changes in the perfusion index that occur during one or more complete respiratory cycle/s.

“Many clinicians around the world rely on pulse oximetry as the fifth vital sign,” stated Joe Kiani, Founder & CEO of Masimo. “The MightySat Rx represents a significant milestone. To deliver Masimo SET performance in this low-power form factor took some engineering, given the precision of our technology and SET’s computationally intensive algorithm. We actually dropped the power consumption by nearly two orders of magnitude. But the development effort was worth it, as we expect this technology will empower clinicians and they will no longer have to compromise performance for mobility.”

MightySat Rx is available in three versions for patients who weigh more than 30 kg (66 lbs):

  • MightySat Rx – Measures and displays SpO2, PR, and PI
  • MightySat Rx, Bluetooth – Adds Bluetooth LE radio for transfer of parameter data to Apple iOS® and select Android™ mobile devices
  • MightySat Rx, Bluetooth and PVI

Standard features include:

  • Measure-Through Motion and Low Perfusion performance
  • Signal I.Q.® to assess measurement confidence
  • Rugged, lightweight design for operation in challenging environments
  • Long battery life–up to 15 hours with two standard AAA alkaline batteries
  • Comfortable design with silicon finger pad to mold to patients’ fingers

Bluetooth is a registered trademark owned by Bluetooth SIG, Inc.
Apple is a registered trademark of Apple Inc. registered in the U.S. and other countries.
IOS is a trademark or registered trademark of Cisco in the U.S. and other countries and is used under license.
Android is a trademark of Google Inc.
MightySat Rx is currently unavailable in the U.S.

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. 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™). 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. @MasimoInnovates

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 MightySat, 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.

Masimo
Mike Drummond
949-297-7434 or 949-648-2269 (mobile)
mdrummond@masimo.com

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