Business Wire

Masimo Announces CE Marking of Eve™ CCHD Newborn Screening Application for the Rad-97™ Pulse CO-Oximeter®

Jaa

Masimo (NASDAQ: MASI) announced today the CE marking of Eve™, a critical congenital heart disease (CCHD) newborn screening application, for the Rad-97™ Pulse CO-Oximeter®. Eve combines the power of Masimo SET® Measure-through Motion and Low Perfusion™ pulse oximetry with a pre-ductal to post-ductal synchronization algorithm designed to reduce calculation errors.

This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20180206006612/en/

Masimo Rad-97™ with Eve™ (Photo: Business Wire)

Masimo Rad-97™ with Eve™ (Photo: Business Wire)

Eve, also available on the Radical-7® Pulse CO-Oximeter, simplifies the CCHD screening process by providing visual instructions, animations, an automatic synchronization algorithm, and a detailed, easy-to-interpret display of screening results. The ability to label results with unique patient identifiers for both mother and newborn facilitates intuitive session management and seamless electronic charting. Eve also allows clinicians to incorporate perfusion index into screening, which has been shown to increase sensitivity to the detection of CCHD in infants with pathologically low perfusion.1

CCHD affects approximately 3 newborns per 1000 live births2 and requires intervention soon after birth to prevent significant morbidity or mortality; later detection in infants also increases the risk of brain damage.3 In a study of 39,821 infants, CCHD screening sensitivity increased from 63% with physical exam alone to 83% with physical exam and Masimo SET® pulse oximetry.4 In a study of 122,738 infants – the largest CCHD screening study to date – CCHD screening sensitivity increased from 77% to 93% with the combined use of Masimo SET® and clinical assessment.5

“Multiple studies have shown that Masimo SET® pulse oximetry can help improve CCHD screening, helping to save many newborns’ lives while reducing the cost of care,” commented Joe Kiani, Founder and CEO of Masimo. “Eve builds on the powerful benefits of SET® by transforming pulse oximeters into intuitive screening tools which can help clinicians perform the crucial work of screening newborns in an easy-to-follow and intuitive application.”

Eve has not obtained FDA clearance and is not available in the United States. Radical-7 and Rad-97 have obtained FDA clearance and are available, without Eve, in the United States.

@MasimoInnovates | #Masimo

References

  1. de-Wahl Ganelli et al. Noninvasive Peripheral Perfusion Index as a Possible Tool for Screening for Critical Left Heart Obstruction. Acta Paediatr. 2007 Oct;96(10):1455-1459.
  2. Hoffman JL et al. The incidence of congenital heart disease. J Am Coll Cardiol. 2002;39(12):1890-1900.
  3. 2011 Legislative Report; State of Maryland, Department of Health and Mental Hygience, State Advisory Council on Hereditary and Congenital Disorders. Recommendations on Implmentation of Screening for Critical Congenital Hearth Disease in Newborns. Page 7.
  4. de-Wahl Granelli A et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009;Jan 8;338.
  5. Zhao et al. Pulse oximetry with clinical assessment to screen for congenital heart disease in neonates in China: a prospective study. Lancet. 2014 Aug 30;384(9945):747-54.

About Masimo

Masimo (NASDAQ: MASI) is a global leader in innovative noninvasive monitoring technologies. Our mission is to improve patient outcomes and reduce the cost of care. In 1995, the company debuted Masimo SET® Measure-through Motion and Low Perfusion™ pulse oximetry, which has been shown in multiple studies to significantly reduce false alarms and accurately monitor for true alarms. Masimo SET® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,1 improve CCHD screening in newborns,2 and, when used for continuous monitoring with Masimo Patient SafetyNet™* in post-surgical wards, reduce rapid response activations and costs.3,4,5 Masimo SET® is estimated to be used on more than 100 million patients in leading hospitals and other healthcare settings around the world,6 and is the primary pulse oximetry at 17 of the top 20 hospitals listed in the 2017-18 U.S. News and World Report Best Hospitals Honor Roll.7 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®), Pleth Variability Index (PVi®), and more recently, Oxygen Reserve Index (ORi™), in addition to SpO2, pulse rate, and perfusion index (Pi). In 2014, Masimo introduced Root®, an intuitive patient monitoring and connectivity platform with the Masimo Open Connect™ (MOC-9™) interface, enabling other companies to augment Root with new features and measurement capabilities. Masimo is also taking an active leadership role in mHealth with products such as the Radius-7™ wearable patient monitor, iSpO2 ® pulse oximeter for smartphones, and the MightySat™ fingertip pulse oximeter. Additional information about Masimo and its products may be found at www.masimo.com. Published clinical studies on Masimo products can be found at http://www.masimo.com/cpub/clinical-evidence.htm.

ORi has not received FDA 510(k) clearance and is not available for sale in the United States.

*The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.

References

  1. Castillo A et al. Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and SpO2 Technology. Acta Paediatr. 2011 Feb;100(2):188-92.
  2. de-Wahl Granelli A et al. Impact of pulse oximetry screening on the detection of duct dependent congenital heart disease: a Swedish prospective screening study in 39,821 newborns. BMJ. 2009;Jan 8;338.
  3. Taenzer AH et al. Impact of Pulse Oximetry Surveillance on Rescue Events and Intensive Care Unit Transfers: A Before-And-After Concurrence Study. Anesthesiology. 2010; 112(2):282-287.
  4. Taenzer AH et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
  5. McGrath SP et al. Surveillance Monitoring Management for General Care Units: Strategy, Design, and Implementation. The Joint Commission Journal on Quality and Patient Safety. 2016 Jul;42(7):293-302.
  6. Estimate: Masimo data on file.
  7. http://health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview.

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 include, among others, statements regarding the potential effectiveness of Masimo SET®, Eve™, Rad-97™, and Radical-7®. 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 belief that Masimo's unique noninvasive measurement technologies, including Masimo SET®, Eve, Rad-97, and Radical-7, contribute to positive clinical outcomes and patient safety; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions and unique advantages; 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.

Contact information

Masimo
Evan Lamb, 949-396-3376
elamb@masimo.com

Tietoja julkaisijasta

For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.

Tilaa tiedotteet sähköpostiisi

Haluatko tietää asioista jo ennen kuin ne uutisoidaan? Kun tilaat tiedotteemme tältä julkaisijalta, saat ne sähköpostiisi yhtä aikaa suomalaisen median kanssa. Tilauksen voit halutessasi perua milloin tahansa.

Lue lisää julkaisijalta Business Wire

Zonoville Investments Limited Announces Agreement on Acquisition of RUSAL Shares19.2.2018 21:19Tiedote

Zonoville Investments Limited, a consortium of investors led by Renova Group and Access Industries, announced today that it had reached an agreement with Onexim Group to purchase its 6% stake in the United Company RUSAL Plc. Following completion of the purchase, Zonoville Investments Limited and its associate SUAL Partners Limited will hold, in aggregate, approximately a 26.5% interest in United Company RUSAL Plc. About Renova Renova Group of companies (www.renova.ru) is a major private Russian business group which owns and manages assets in metallurgy, mining, chemical, construction, transport, energy, telecommunications, high-tech engineering, public utilities, medicine and financial sectors in Russia and abroad (CIS, Switzerland, Italy, South Africa and the United States of America). Renova’s largest assets include its interests in UC Rusal, T Plus Group, OCTO Telematics and Swiss-based technology concerns Schmolz+Bickenbach, OC Oerlikon, and Sulzer. About Access Industries Founded

The Digital Health Technology Show: The Leading Show for Healthcare Innovation Comes to London19.2.2018 21:05Tiedote

Medical innovation will take centre stage for 2018, at the largest wearables and disruptive health technology event in the world, with never before-seen devices and applications and a raft of industry-leading speakers. The Digital Health Technology Show returns to London on the 13th & 14th March 2018 at London’s Excel, gathering together more than 6,000 attendees and over 100 exhibitors. The 2018 Conference programme boasts three tracks, with over 100 hours of content programmed. Attendees can choose to attend talks on the Digital Health Disrupt Stage – covering global innovation in healthcare, the Leadership Theatre – where senior healthcare figures in the UK will discuss and debate the challenges ahead, or the Patient Engagement Stage – delivering insights into how technology is being used in the real world. There will also be demonstrations of the latest medical innovations on the Innovation Stage, which will also host a start up competition – The Health Innovation Award. Over 200 s

World Patient Safety Summit is Sold Out But Space is Available at the Breakout Sessions, Held the Day after the World Summit, at the Royal Society in London19.2.2018 16:00Tiedote

The latest advances in vaccine safety, reducing unnecessary C-sections and person & patient engagement will be among the varied breakout sessions offered the day after the 6th Annual World Patient Safety, Science & Technology Summit in London by the Patient Safety Movement Foundation. The breakout sessions will convene on Sunday, February 25, 2018 at the prestigious Royal Society, the independent scientific academy of the United Kingdom and the Commonwealth, dedicated to promoting excellence in science. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20180219005119/en/ Limited Space available to participate with experts at the 6th Annual World Patient Safety, Science & Technology Summit Break Out Sessions at the Royal Society in London (Photo: Business Wire) The breakout sessions are full-day working meetings structured for shared learning on existing Actionable Patient Safety Solutions (APSS) – collaborative, evidence-based pro

Tampere Attracts AV Productions with a New Incentive19.2.2018 15:41Tiedote

One of the City of Tampere’s strategic goals is to be an international meeting place for creativity and innovation. The development of the experience economy is an essential focus of the city’s business policy. The incentive system is being used to attract more local, national and international productions to the Tampere region. The goal is to promote the development of the industry and to increase the number of jobs and the turnover of commercial productions in Tampere. Through the incentive system, an audiovisual production may recover some of the costs it has spent on wages and service purchases in the Tampere region. A production meeting the incentive criteria may be refunded 10–15 per cent of the accepted costs accrued in the region. Professional productions that utilise the Tampere region as their location or use expertise from the area may apply for the incentive. Thanks to the growing number of productions, Tampere will become more visible in films and TV shows, which will add

Tempo Grows Revenue by 38% in 2017 to $17.9 Million19.2.2018 14:14Tiedote

Tempo, creator of efficiency-enhancing project management software solutions for Atlassian’s Jira platform, announced strong results for its 2017 fiscal year ending December 31, 2017. “2017 marks another productive and successful year for Tempo, with December our highest grossing month ever and sales across our product range exceeding expectations,” commented Agust Einarsson, CEO, “The completion of our new cloud infrastructure and successful migration of our entire customer base to Amazon Web Services (AWS) marks a strategic milestone, empowering Tempo with a more scalable underlying platform and enabling us to deploy products to customers faster.” Highlights for 2017 include: Revenue grew 38% year-over-year to US$17.9 million Almost 2,000 new customers were acquired Launched our new cloud infrastructure Expanded product footprint beyond the Atlassian environment with Tempo for Slack North American operations continued to grow More than 120 partners worldwide Celebrated our 10-year an

Morrow Sodali Announces Appointment of David Shammai as Corporate Governance Director - Cross Border19.2.2018 13:05Tiedote

Morrow Sodali today announced that David Shammai has joined the firm as Corporate Governance Director - Cross Border. David joins from APG Asset Management, the Dutch pension fund manager, where in his role as senior corporate governance specialist he was involved in voting, policy, and engagement. Based in the London office, David will focus on the firm’s growing corporate governance activities across its European offices. Together with Morrow Sodali’s expanding team of corporate governance professionals, David will work to further develop the firm’s governance services – ranging from benchmarking and assessments of governance practice to board advisory on engagement with investors. “At Morrow Sodali we recognise that today many of our clients face growing needs for an in-depth and meaningful dialogue with their investors on a broadening range of topics. Having David onboard - from one of the world’s largest fiduciary asset managers - demonstrates our reinforced commitment to helping

Uutishuoneessa voit lukea tiedotteitamme ja muuta julkaisemaamme materiaalia. Löydät sieltä niin yhteyshenkilöidemme tiedot kuin vapaasti julkaistavissa olevia kuvia ja videoita. Uutishuoneessa voit nähdä myös sosiaalisen median sisältöjä. Kaikki STT Infossa julkaistu materiaali on vapaasti median käytettävissä.

Tutustu uutishuoneeseemme