Business Wire

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

Del

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

Om Business Wire

Business Wire
Business Wire
24 Martin Lane
EC4R 0DR London

+44 20 7626 1982http://www.businesswire.co.uk

(c) 2018 Business Wire, Inc., All rights reserved.

Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.

Følg saker fra Business Wire

Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.

Siste saker fra Business Wire

IWBI Launches Global Network of Advisors for WELL Portfolio16.10.2018 18:00Pressemelding

The International WELL Building Institute™ (IWBI™) today announced the formation of a global advisory to help shape and advance the implementation of the WELL Portfolio™ Pathway pilot, a new streamlined pathway for WELL Certification™ for multiple new or existing buildings and tenant spaces in a single portfolio. WELL Portfolio, announced this past month, is being released as part of the WELL v2™ pilot, the latest iteration of the WELL Building Standard™ (WELL™). It is part of a suite of enhancements to WELL that addresses growing demand across the building industry for a program that helps owners, developers and tenants streamline and scale health and wellness upgrades to their real estate assets. The advisory includes a collection of professionals, practitioners and experts across a range of industries and sectors, each serving a one-year term. “Since we launched WELL, we’ve seen an explosion of interest from global companies to bring the same health and wellness benefits across thei

The X7 Delivers Right-sized Packaging Automation from Packsize While Reducing Labor, Shipping, and Material Costs16.10.2018 17:55Pressemelding

The continued decline in unemployment is impacting companies across nearly every industry; a reported 3.7 percent national average in September by the U.S. Department of Labor. Heightened demand for goods ordered over the internet amplifies the worker shortage for these companies shipping products. To ensure optimal and timely outcomes and smart industry improvements for its customers, Packsize today announces its fully automated, right-sized packaging system, the X7™. The new automated custom box-making system represents a significant investment by Packsize in machine learning, packaging process automation, corrugated infrastructure and testing, and business intelligence. The automated system is the second in the company’s X Series line of automated, On Demand Packaging® technology solutions. Advancing packaging automation for complex, single- and multiple-item orders, the X7™ achieves sustainability and supply chain workflow optimization. Delivering the most needed functions to make,

Event Software Company Aventri Acquires ITN International16.10.2018 16:00Pressemelding

Leading event management software company Aventri announced the acquisition of ITN International, the industry leader in NFC, mobile and cloud-based technology. With the acquisition of ITN, Aventri will broaden its technology and service offerings, expanding its global reach and the events that they support. Servicing annually 125 events, 10,000 exhibitors and 1.5 million attendees, ITN serves event producers by combining technology with personalized professional services to optimize events. A look at their product set includes: Online registration system with speaker management, agenda builder, session scheduling, and more. Onsite services include NFC badges, check-in stations, lead retrieval, apps, RFID scanning and more. Data visualization tools with advanced reporting and analytics around registration, badge activity and scans. “The acquisition of ITN as a global provider of cloud-based event management solutions is a major growth opportunity for Aventri,” says Oni Chukwu, CEO of A

Thales and Gemalto Are Granted Regulatory Clearance from the Competition Commission in South Africa16.10.2018 16:00Pressemelding

Regulatory News: Reference is made to the joint press release by Thales (Euronext Paris: HO) and Gemalto (Euronext Amsterdam and Paris: GTO) dated 27 March 2018 in relation to the launch of the recommended all-cash offer by Thales for all the issued and outstanding shares of Gemalto (the “Offer”), the publication of the Offer Document, and the joint press release of Thales and Gemalto dated 10 August 2018 in relation to the further extension of the Acceptance Period. Terms not defined in this press release will have the meaning as set forth in the Offer Document. Thales and Gemalto today announce that they have received Regulatory Clearance from the Competition Commission in South Africa. Together with the antitrust clearances obtained in China, Israel and Turkey, and clearances relating to foreign investments in Australia, Canada and the USA (CFIUS), Thales and Gemalto have now obtained 7 of the required 14 Regulatory Clearances. Thales and Gemalto continue to work constructively with

Piraeus Bank Finances the Development of Thriassio Transit Center16.10.2018 15:39Pressemelding

Piraeus Bank will finance the development of the Thriassio Transit Center, which will help increase freight transport by rail and promote Greece as a major freight hub in the trans-European transport network. The Center will significantly increase freight transport by rail and promote Greece as a major freight hub in the trans-European transport network. It will contribute to the provision of upgraded services while also reducing transport costs, which are key factors in lowering the final price of products, having a direct positive impact on the competitiveness of the economy and GDP growth. The project is also expected to boost local employment, creating up to 5,000 jobs over the next 10 years. The new Thriasio Transit Center is expected to become operational in 2024. Piraeus Bank Chief Executive Officer, Mr. Christos Megalou said: “Piraeus Bank are always looking for suitable investment projects that align with our strategy to be a pillar of stability for the Greek economy and we ar

Inside Secure’s Latest Whitebox Software Security Tool Brings Mobile Developers New Levels of Protection, Performance and Control16.10.2018 15:36Pressemelding

Regulatory News: Inside Secure (Paris:INSD), at the heart of security solutions for mobile and connected devices, today announced general availability of its Whitebox 3.0 software crypto-security tool that protects cryptographic keys and algorithms inside mobile applications that demand top-notch security. Inherently running in an exposed environment, mobile applications are susceptible to attackers who can then see all the secrets within the app. As a proven innovator in software security, Inside Secure builds on numerous years of successful integrations for top developers to offer the best technology for hiding data and cryptography on mobile devices. Serving as an appealing alternative to an expensive, hardware-dependent Trusted Execution Environment (TEE) or Secure Element (SE) Whitebox 3.0 secures assets with uniquely powerful features that bring industry-changing gains in performance and flexibility – key traits that developers demand. Inside Secure’s pure software approach means