Masimo Announces CE Marking and Release of Oxygen Reserve Index™ rainbow Lite Sensors
Masimo (NASDAQ: MASI) announced today the CE marking and release of RD rainbow Lite SET™ sensors, which enable the monitoring of Masimo Oxygen Reserve Index™ (ORi™) and RPVi™, an improved PVi® that allows clinicians to assess fluid responsiveness noninvasively and continuously1 at a fraction of the cost of invasive methods, and at a fraction of the cost of rainbow® sensors. rainbow Lite sensors utilize twice as many wavelengths of light as SET® sensors, allowing rainbow Lite sensors to provide ORi and RPVi along with Masimo SET® Measure-through Motion and Low Perfusion™ pulse oximetry.
This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20180101005082/en/
Masimo RD rainbow Lite SET™ Sensor (Photo: Business Wire)
ORi is the first noninvasive and continuous parameter to provide insight into a patient’s oxygen reserve in the moderate hyperoxic range. In conjunction with SET® pulse oximetry, ORi may provide advanced warning of impending desaturation, which may allow clinicians to intervene sooner. For example, in a study of 25 pediatric patients undergoing general anesthesia with orotracheal intubation, researchers found that ORi helped clinicians identify impending desaturation a median of 31.5 seconds before noticeable changes in oxygen saturation (SpO2) occurred.2 In another recent study of 106 adult patients scheduled for surgery with arterial catheterization and intraoperative blood gases analyses, researchers found a significant relationship between change in PaO2 and change in ORi.3 In addition, ORi may provide insight into oxygen reserve when titrating patients who are receiving supplemental oxygen.4
Joe Kiani, Founder and CEO of Masimo, said, “rainbow Lite sensors allow clinicians, who depend on powerful SET® pulse oximetry technology, to augment their patient monitoring with ORi and newly introduced RPVi. Given the positive reception of ORi in available markets, and feedback from clinicians who see great value in the benefits of ORi monitoring, we are excited to make ORi and RPVi accessible via the cost-effective solution represented by RD rainbow Lite SET. Hospitals that standardize on RD rainbow Lite SET will pay only nominally more per sensor than for SET®.”
Masimo RPVi is a multi-wavelength version of Pleth Variability Index (PVi). RPVi is designed to provide enhanced assessment of changes in fluid volume compared to PVi5, which has been shown in over 90 independent clinical studies to be as effective as invasive monitoring methods.6
With the addition of RD rainbow Lite SET, the RD family of sensors is now available in three levels of capability: RD SET, utilizing two wavelengths (2 LED) and featuring SET® pulse oximetry; RD rainbow Lite SET, which utilizes four wavelengths (4 LED) and adds the ability to measure ORi and RPVi; and RD rainbow SET, which utilizes over seven wavelengths (7+ LED) and enables the measurement of additional advanced noninvasive parameters such as SpHb® (total hemoglobin), SpCO® (carboxyhemoglobin), SpMet® (methemoglobin), and SpOC™ (oxygen content).
Like RD SET sensors, RD rainbow Lite SET sensors are designed to maximize patient comfort and optimize clinician workflow. The sensors are lightweight and have a flat, soft cable with smooth edges, so that they lie comfortably on a patient’s hand or foot. The sensors feature an intuitive sensor-to-cable connection, with tactile and audible feedback to ensure a proper connection, and have graphics printed on both sides to assist with application.
Devices with ORi and RPVi measurements and RD rainbow Lite SET sensors have not received FDA 510(k) clearance and are not available for sale in the United States.
@MasimoInnovates | #Masimo
- Forget P, Lois F, de Kock M. Goal-Directed Fluid Management Based on the Pulse Oximeter-Derived Pleth Variability Index Reduces Lactate Levels and Improves Fluid Management. Anesth Analg. 2010 Oct; 111(4):910-4.
- Szmuk P, Steiner JW, Olomu PN, Ploski RP, Sessler DI, and Ezri T. Oxygen Reserve Index A Novel Noninvasive Measure of Oxygen Reserve—A Pilot Study. Anesthesiology. 4 2016, Vol. 124, 779-784. doi:10.1097/ALN.0000000000001009.
- Applegate R, Dorotta I, Wells B, Juma D, and Applegate P. The Relationship Between Oxygen Reserve Index and Arterial Partial Pressure of Oxygen During Surgery. Anesth Analg. 2016 Sep; 123(3); 626-633.
- Scheeren TWL, Belda FJ and Perel A. The oxygen reserve index (ORi): a new tool to monitor oxygen therapy. J Clin Monit Comput. 2017. doi:10.1007/s10877-017-0049-4.
- Masimo data on file.
- Published clinical studies on PVi can be found at http://www.masimo.com/en-GB/home/clinical-evidence/pleth-variability-index-pvi/.
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.
- 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.
- 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.
- 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.
- Taenzer AH et al. Postoperative Monitoring – The Dartmouth Experience. Anesthesia Patient Safety Foundation Newsletter. Spring-Summer 2012.
- 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.
- Estimate: Masimo data on file.
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 RD rainbow Lite SET™ sensors, ORi™, RPVi™, and PVi®. 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 RD rainbow Lite SET sensors, ORi, RPVi, and PVi, 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.
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
GSMA Announces Nominees for 2018 GLOMO Awards24.1.2018 12:00 | Tiedote
The GSMA today announced the nominees for the Global Mobile Awards 2018 (GLOMO Awards). Winners of the awards will be presented throughout Mobile World Congress, which takes place 26 February – 1 March in Barcelona. The full list of nominees can be found at http://gsma.at/glomoshortlist. "The GLOMOs offer organisations and individuals from across the world an opportunity to showcase how mobile technology continues to inspire new levels of ingenuity, innovation and achievement,” said Michael O’Hara, Chief Marketing Officer, GSMA. “As always, the calibre of entries is extremely high, so to be shortlisted for the GLOMOs today is quite an achievement in itself. We wish the very best of luck to all nominees and look forward to unveiling the winners at Mobile World Congress next month.” The GLOMO Awards feature an afternoon ceremony at 15:30 CET on Tuesday, 27 February in Auditorium 5, Hall 4, and will include the presentation of winners in three categories including “Social Good”, “Governme
GleSYS Tap Into Telia Carrier Backbone to Increase Capacity and Support Growth Plans24.1.2018 12:00 | Tiedote
Telia Carrier announced today that it is working with one of Sweden’s fastest growing hosting companies, GleSYS , to provide improved capacity and support future growth plans. GleSYS will be connecting to the Telia Carrier global backbone, one of the largest in the world, and the first to be 100G enabled in Europe and North America. GleSYS provides hosting and data centre services to over 4,000 customers in 70 countries. With two fully redundant datacentres in Sweden and a network of cloud hosting locations, GleSYS supports a range of industries, such as eCommerce, where performance, responsiveness and reliability on a global scale have a direct impact on revenues and are therefore critical. Telia Carrier will be providing 100G IP Transport and wavelength network transport services to double available capacity on GleSYS’ current infrastructure, which provides cloud hosting, dedicated servers and colocation in multiple sites across Europe. Eric Lindsjö, Head of Networks at GleSYS, said;
Düsseldorf Airport to Deploy Next Generation ECAC Standard 3 EDS Screening Technology from Smiths Detection24.1.2018 12:00 | Tiedote
Smiths Detection is supplying next generation hold baggage scanners to support the upgrade to ECAC Standard 3 explosives detection systems (EDS) at Düsseldorf Airport. Awarded by the Procurement Office of the German Ministry of Interior, the contract includes 14 advanced HI-SCAN 10080 XCT scanners, which deliver exceptional levels of security; and can be further updated as necessary in the future to detect new explosive threats. There is also an associated eight year service agreement. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20180124005070/en/ Düsseldorf Airport to deploy next generation ECAC Standard 3 EDS screening technology from Smiths Detection (Photo: Business Wire) “European airports are currently very focused on upgrading to ECAC Standard 3 approved EDS to meet the new regulations,” commented Tony Tielen VP EMEA, Smiths Detection. “This does, of course, require a financial investment which must be clearly weighed
Integral Expands Cryptocurrency Market Data Services to Include 14 Cryptocurrencies and 16 Exchanges24.1.2018 01:00 | Tiedote
Integral (www.integral.com), the financial technology partner trusted by leading banks, brokers, and investment managers to design, deliver and grow their FX businesses, announced today that it has expanded its market data offering for cryptocurrencies to include 14 major cryptocurrencies connecting to all major exchange sources across the U.S., Europe and Asia including Japan and Hong Kong. “An accurate, stable, and reliable reference price is a requirement for any market maker,” said Harpal Sandhu, CEO of Integral. “The Cryptocurrency Market Data Service connects to the most price sources and applies the most advanced price discovery algorithm available.” Integral has years of experience as a technology leader and innovator in foreign exchange and is now applying this ingenuity to the cryptocurrency market. The Market Data Service uses algorithms developed with Stanford University for Integral FX Benchmark to provide the most precise reference prices for cryptocurrencies. “Integral’s
Kimbal Riley to Become Vista Group CEO24.1.2018 00:57 | Tiedote
Vista Group International (NZX & ASX: VGL) has today announced that Kimbal Riley will take over as Group CEO from Murray Holdaway. Mr Holdaway will take up the position of Chief Product Officer (CPO) for Vista Group, and will continue in his role as an Executive Director on the Vista Group board. This has taken place as part of a succession planning process and will deliver a seamless transition within the business. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20180123006545/en/ Kimbal Riley becomes CEO of Vista Group International (Photo: Business Wire) Mr Riley has had an extensive career in senior executive roles in the IT and Services industries in New Zealand and overseas. He joined Vista Group four years ago, with the past two years as CEO of Vista Entertainment Solutions (VES), which is responsible for the largest proportion of the Group’s revenue. He has been focused on building scale in the business and under his lea
IFF Breaks Ground on Flavors/Fragrances Site in Sri City, India23.1.2018 20:00 | Tiedote
Regulatory News: International Flavors & Fragrances Inc. (NYSE: IFF) (Euronext Paris: IFF), a leading innovator of sensory experiences that move the world, has broken ground on a new flavors and fragrances plant located in Sri City, in the State of Andhra Pradesh in India. Part of a larger investment into the Greater Asia region, the plant is expected to be commercialized in December 2019. The new facility, which will be the largest flavor and fragrance manufacturing facility in India and the largest IFF site in Greater Asia, occupies a 32-acre/130,000m2 plot and will serve IFF flavors and fragrances customers across India and the region. “In this economically vibrant country, it is critical that we invest to provide our customers with winning tastes and scents,” said IFF Chairman and CEO Andreas Fibig. “This new facility is fitted with capabilities tailored for our customers’ needs. Coupled with our excellent consumer insights teams and their deep understanding of the local markets, w
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