IRVINE, Calif.--(BUSINESS WIRE)--Masimo (NASDAQ: MASI) announced today the CE marking of the Rad-97™ Pulse CO-Oximeter® with integrated NomoLine™ capnography. With this clearance, Rad-97 is now available both within and outside the United States in three configurations: Rad-97, Rad-97 with integrated noninvasive blood pressure, and now Rad-97 with NomoLine capnography. Rad-97 offers Masimo noninvasive and continuous monitoring, through Measure-through Motion and Low Perfusion™ SET® pulse oximetry, upgradeable rainbow® technology, and NomoLine capnography in a compact, standalone monitor that incorporates advanced customizability, connectivity, and device integration capabilities.
Rad-97 with NomoLine capnography features an integrated ISA™ CO2 module with NomoLine sampling lines for sidestream capnography, with an adapter for intubated patients – meeting continuous monitoring and capnography needs in a single device. Rad-97 with capnography displays continuous end-tidal carbon dioxide (EtCO2) values with numeric, trend, and waveform viewing options, as well as fractional concentration of inspired carbon dioxide (FiCO2) and respiration rate. With both integrated capnography and Masimo acoustic respiration rate (RRa®) available on a single device, clinicians have the flexibility of choosing the most appropriate respiration monitoring method for each patient.
Rad-97 combines its portable, compact form factor with a high-resolution, multi-touch color display that allows clinicians to easily customize the device for each monitoring use case – bringing rainbow SET™ measurements and capnography measurements to care areas where a small footprint or high portability is desired. Rad-97 features built-in enterprise WiFi capability, allowing it to connect wirelessly to supplemental patient monitoring systems including Masimo Patient SafetyNet™*, facilitating automatic data transfer to hospital electronic medical record (EMR) systems. The easy-to-use, intuitive interface helps to simplify charting workflows for vital sign monitoring and patient data capture.
“We’re delighted to bring the full family of Rad-97 products to markets outside the United States,” said Joe Kiani, Founder and CEO of Masimo. “We believe Rad-97, with its versatility and customizability, will play an especially important role in helping hospitals improve their monitoring capabilities with convenient, easy-to-use device and technology solutions – ultimately helping to improve patient care and safety.”
Rad-97, Rad-97 with noninvasive blood pressure, and Rad-97 with NomoLine capnography have received FDA 510(k) clearance and are also available in the United States.
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*The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.
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://www2.masimo.com/evidence/featured-studies/feature/.
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 Rad-97™ and NomoLine™. 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 Rad-97 and NomoLine, 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.
