Business Wire

Study Evaluates Performance of Masimo iSpO2® Rx Smart Device-Paired Pulse Oximeter in Screening Newborns for Critical Congenital Heart Disease

Jaa

Masimo (NASDAQ: MASI) announced today the findings of a recently published study in which researchers in Maastricht, The Netherlands evaluated the performance of Masimo iSpO2 ® Rx in screening newborns for critical congenital heart disease (CCHD).1 iSpO2 Rx is a smart device-paired pulse oximeter featuring Masimo Measure-through Motion and Low Perfusion™ pulse oximetry technology.

CCHD affects approximately 2.5 to 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 the study, Dr. Huizing and colleagues sought to evaluate the accuracy of iSpO2 Rx because of increasing trends toward out-of-hospital births and concerns about the costs of CCHD screening implementation in low-resource settings. The researchers surmised that a portable, low-cost pulse oximeter may be more practical in such settings than standalone hospital devices.

The researchers enrolled 201 infants in the study. CCHD screening was conducted 12-24 hours after birth by two independent teams, who were blinded to the other team’s results. Each team took both preductal (right-hand) and postductal (either foot) SpO2 measurements to establish whether an infant passed, failed, or needed a repeat screening. One team measured oxygen saturation using a Masimo Radical-7® Pulse CO-Oximeter® equipped with disposable Masimo LNCS® sensors. The other team used a Masimo iSpO2 Rx equipped with a reusable M-LNCS™ YI sensor, connected to an Apple iPad Mini.

Applying Bland-Altman analysis to the preductal SpO2 values of the 201 screened infants, with Radical-7 as the reference device, the researchers calculated a mean bias of -0.08% ± standard deviation of 1.76%, with limits of agreement of -3.52% and 3.36%. For postductal SpO2 values, they calculated a mean bias of -0.11% ± standard deviation of 1.68%, with limits of agreement of -3.41% and 3.18%.

In addition, to evaluate the ability of iSpO2 Rx to measure low oxygen saturation, the researchers also enrolled a group of 12 infants admitted to the neonatal intensive care unit (NICU) with SpO2 lower than 95%. SpO2 was continuously monitored for 10 minutes, with readings recorded once per minute, and with one foot connected to the iSpO2 Rx and the other to a Philips IntelliVue MP70 monitor equipped with Masimo SET® technology. Using the Philips monitor as the reference device, the researchers calculated a mean bias of 0.01% ± standard deviation of 1.74%, with limits of agreement of -3.42% and 3.43%.

The researchers concluded that, “Our data suggest that CCHD screening with the Masimo iSpO2 Rx is feasible and accurate. The use of reliable smartphone-paired pulse oximeters may contribute to the extension of CCHD screening to home births and low resource settings.” They also noted that, “The iSpO2 Rx demonstrated a high degree of agreement with the Masimo Radical-7, a hospital-grade pulse oximeter.”

The device used in this study is iSpO2 Rx. The study did not use the iSpO2, which is intended as an exercise and wellness product and is not available for use on neonates. iSpO2 is not intended for CCHD screening or any other medical use.

iSpO2 Rx does not have 510(k) clearance and is not available for sale in the United States.

@MasimoInnovates | #Masimo

References

  1. Huizing M, Villamor-Martinez-E, Chavagne I, Vanagt W, Spaanderman M, and Villamor E. Reliability and Validity of a Smartphone-Paired Pulse Oximeter for Screening of Critical Congenital Heart Defects in Newborns. Neonatology. 2017;112:324–329. DOI: 10.1159/000477294.
  2. Hoffman JL et al. The incidence of congenital heart disease. J Am Coll Cardiol. 2002 Jun 19;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 Implementation of Screening for Critical Congenital Heart Disease in Newborns. Page 7.

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 16 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;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 Radical-7® Pulse CO-Oximeter® and iSpO2 ® Rx. 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 Radical-7 Pulse CO-Oximeter and iSpO2 Rx, 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

World’s 1st End-to-End Digital TETRA DAS for Critical Communications and Public Safety Networks by Maven Wireless.25.9.2017 16:40Tiedote

Maven Wireless, the game changer in wireless coverage, announced the arrival of the world’s 1 st end-to-end digital TETRA DAS, (Distributed Antenna System) for in-building coverage at, Critical Communications MENA 2017 in Dubai. Operators of Critical Communications and Public Safety networks are moving toward combining effective voice communication capabilities with nationwide public safety LTE networks, enabling features such as video streaming, file sharing and real-­time analytics, without compromising security. As TETRA is still being deployed by operators across the world, the networks must support coexistence between TETRA and public safety LTE. Maven Wireless is now introducing the world’s 1st end-to-end digital TETRA DAS system for Critical Communications networks to the market. ‘’Maven DAS e

The Geneva Association: Life Insurers Should Prepare for Implications of Genetics in Highly Fragmented Regulatory Landscape25.9.2017 15:00Tiedote

The Geneva Association, the leading international think tank of the insurance industry, has released the research paper Genetics and Life Insurance: A view into the microscope of regulation, in which it reviews key aspects of the use of genetic information in life insurance. The use of genetic information for life, disability, critical illness and long-term care insurance is likely to increase in spite of a highly fragmented regulatory environment. The growing availability of genetic testing at ever lower prices is already giving insureds the option to purchase online “direct-to-consumer” tests. One of the questions raised is whether policyholders should be required to share their genetic information with life insurers. The paper focuses specifically on the regulatory implications of genetic testing. Ronald Klein, Director of The Geneva Association’s Global Ageing res

Saudi Arabia Marks 87th National Day With Series of Concerts, Plays and Entertainment Events25.9.2017 02:40Tiedote

Saudi National Day celebrations continue apace through the holiday weekend, with a series of spectacular entertainment events across the Kingdom highlighting the country’s achievements. This Smart News Release features multimedia. View the full release here: http://www.businesswire.com/news/home/20170924005034/en/ The 99-story Kingdom Centre in Riyadh is illuminated against the night sky on September 23 with the portrait of sprinter Kariman Abuljadayel, who was a member of the Saudi contingent to the Rio Olympics in 2016. The Kingdom is celebrating the 87th anniversary of its founding with a series of spectacular entertainment events across the Kingdom highlighting the country's achievements. CIC/General Entertainment Authority (Photo: AETOSWire) According to the General Entertainment Authority - the body responsible for expanding the entertainment sector under Vision 2030 - a total of 27

California Sports Surfaces Announces New Senior Leadership22.9.2017 23:21Tiedote

The California Sports Surfaces (CSS) brand, as part of ICP Construction (ICP), today announces the appointments of Steve Lock as global vice president; John Graham as leader, strategic accounts and global relationships; and Malcolm Parkes as managing director, Australia California Sports Surfaces. CSS is the leading supplier of such prestigious sports surfacing solutions as DecoTurf, Plexicushion Prestige, Rebound Ace, Premier Sports Coatings, Premier Court and Plexitrac. These world-renowned product lines supply the US Open, the Australian Open and other distinguished sporting events. Steve Lock has assumed the role of global vice president, responsible for managing the US and global sales and marketing teams for California Sport Surfaces. He was previously the leader for California Sports Surfaces in Australia and the Asia/Pacific region, and will be relocating to ICP global headquar

CORRECTING and REPLACING Smiths Detection Wins Biggest Ever Single Order for Next-Generation Hold Baggage Scanner for Frankfurt Airport22.9.2017 19:02Tiedote

Please replace the release with the following corrected version due to multiple revisions to the headline, subhead and body of the release. The corrected release reads: SMITHS DETECTION WINS BIGGEST EVER SINGLE ORDER FOR NEXT-GENERATION HOLD BAGGAGE SCANNER FOR FRANKFURT AIRPORT Advanced HI-SCAN 10080 XCT hold baggage scanners offer flexible, sophisticated detection capabilities Smiths Detection has won its largest single order ever for its advanced HI-SCAN 10080 XCT hold baggage scanners, with an associated eight-year service agreement. The contract covers 35 of our HI-SCAN 10080 XCT next-generation scanners to support the upgrade to the ECAC Standard 3 explosives detection systems. The solution will deliver increased security and operational efficiency, and can easily be upgraded to mee

California Sports Surfaces’ Rebound Ace Portable Court to be Used at Inaugural Laver Cup22.9.2017 17:37Tiedote

California Sports Surfaces (CSS), a brand under ICP Construction (ICP), is pleased to announce its innovative Rebound Ace Portable sport surfacing system is being used in the inaugural Laver Cup in Prague, Czech Republic, Sept. 22-24, 2017. CSS’s Rebound Ace system was selected to provide comfort, consistency and playability to the Laver Cup participants, who represent the best tennis players in the world. For this event, organizers worked with California Sports Surfaces to create a stunning black surface that would keep spectators focused on the game play. Rebound Ace Portable is an interlocking, temporary court system that provides premium cushion and comfort to maximize players’ performance. It has been chosen for use for several high-profile events, including the Fed Cup, Davis Cup, and the Singapore-based WTA Finals, for which it was specifically created. Laver Cup is modeled afte

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