NEUCHATEL, Switzerland–(BUSINESS WIRE)–Jan 9, 2023–
Fields (NASDAQ: MASI) today announced the results of an im American Journal of Emergency Medicine published prospective study in which Dr. Zohair Ahmed Ali Al Aseri and his colleagues from King Saud University Medical City and Dar Al Uloom University (Riyadh, Saudi Arabia) evaluated the performance of noninvasive hemoglobin spot check measurement with Masimo SpHb ® in emergency room patients. Researchers concluded that SpHb offers “acceptable accuracy and excellent correlation” with their invasive laboratory measurements and represents a “simple, rapid, practical, inexpensive, and accurate solution for Hb testing in the emergency room.” 1
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Masimo Rad-67® with SpHb® (Photo: Business Wire)
Given that while invasive hemoglobin measurement is an important step in treating blood loss, it also has disadvantages such as: For example, “the consumption of valuable time, phlebotomy-related anemia, pain, infection, and greater demands on staff and equipment,” the study authors wanted to find out if a noninvasive method could provide similarly accurate results while mitigating some of these factors. To compare noninvasive and invasive measurements, they enrolled 650 patients (age > 14 years) who attended the emergency departments of two hospitals at King Saud University Medical City between March and May 2022 and required a complete blood count. Hemoglobin was measured non-invasively (SpHb) using the Masimo Rad-67 ® Pulse CO-Oximeter ® with the DCI ® -mini finger sensor. Blood samples were collected at the same time and analyzed at the time of collection (LabHb) using the UniCel DxH 800 Coulter Cellular Analysis System automated analyzer.
The researchers found a “highly significant correlation” between SpHb and LabHb (Pearson’s correlation coefficient = 0.812, p<0.01). Bland-Altman analysis revealed a low mean error of 0.146 g/dL ± 1.39 g/dL, with moderate limits of agreement (-2.58 and 2.87 g/dL) and a margin of error (95% confidence interval) of 2 .7 g/dL.
Scientists concluded that “noninvasive hemoglobin (SpHb) measurement has acceptable accuracy and excellent correlation with LabHb and provides a simple, rapid, practical, inexpensive, and accurate solution for Hb measurement in the emergency department. Further research is needed to examine the effects on patient outcomes, blood transfusion, and time and cost efficiencies.”
SpHb monitoring is not intended to replace laboratory blood testing. Clinical decisions based on red blood cell transfusions should be made by the physician after considering at least the following aspects: the patient’s condition, continuous SpHb monitoring and diagnostic laboratory tests on blood samples.
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About Masimo
Masimo (NASDAQ: MASI) is a global medical technology company that designs and manufactures a wide range of industry-leading monitoring technologies, including innovative meters, sensors, patient monitors, automation and connectivity solutions. In addition, Masimo Consumer Audio is home to eight legendary audio brands including Bowers & Wilkins, Denon, Marantz and Polk Audio. Our goal is to improve life, increase patient outcomes and reduce the cost of care. Introduced in 1995, Masimo SET ® Measure-through Motion and Low Perfusion™ pulse oximetry has been shown to be superior to other pulse oximetry technologies in over 100 independent and objective studies. 2 Masimo SET ® has been shown to help physicians reduce severe retinopathy of prematurity in newborns, 3 improve CCHD screening in newborns 4 and, with continuous monitoring with Masimo Patient SafetyNet™ in postoperative wards, reduce Rapid Response Team visits, transfers to to reduce the intensive care unit and costs. 5-8 Masimo SET ® is estimated to be used on more than 200 million patients in leading hospitals and other healthcare settings around the world 9 and is the primary pulse oximetry in 9 of the top 10 hospitals performing in the 2022-23 U.S. News and World Report Best Hospitals Honor Roll are listed. 10 In 2005, Masimo introduced rainbow ® Pulse CO-Oximetry technology, which enables non-invasive and continuous monitoring of blood components that previously could only be measured invasively, including total hemoglobin (SpHb ® ), oxygen content (SpOC™), Carboxyhemoglobin (SpCO ® ), Methaemoglobin (SpMet ® ), Pleth Variability Index (PVi ® ), RPVi™ (rainbow ® PVi) and Oxygen Reserve Index (ORi™). In 2013, Masimo introduced the Root ® patient monitoring and connectivity platform, designed from the ground up to be as flexible and extensible as possible to facilitate the addition of other Masimo and third-party monitoring technologies. Key additions from Masimo include next-generation SedLine ® brain function monitoring, O3 ® regional oximetry and ISA™ capnography with NomoLine ® sampling lines. Masimo’s family of continuous and spot-check Pulse CO-Oximeters ® includes devices designed for use in a variety of clinical and non-clinical scenarios, including tetherless, wearable technology such as the Radius-7 ® , Radius PPG ® and Radius VSM ™, handheld devices like the Rad-67 ®, fingertip pulse oximeters like the MightySat ® Rx, and devices that can be used both in the hospital and at home, like the Rad-97 ®. Masimo’s hospital and home automation and connectivity solutions are centered on the Masimo Hospital Automation™ platform and include Iris ® Gateway, iSirona™, Patient SafetyNet, Replica ®, Halo ION ®, UniView ®, UniView :60™ and Masimo SafetyNet ® . The growing portfolio of health and wellness solutions includes Radius Tº ® and the Masimo W1™ watch. For more information about Masimo and its products, visit www.masimo.com. For published clinical studies on Masimo products, visit www.masimo.com/evidence/featured-studies/feature/.
ORi, RPVi and Radius VSM are not FDA 510(k) cleared and are not commercially available in the United States. Use of the Patient SafetyNet trademark is licensed by the University HealthSystem Consortium.
Credits
- Al Aseri ZAA, Aldawood BA, Altamimi et al. Accuracy of noninvasive hemoglobin level measurement in the emergency department. Amer J Emerg Med.https://doi.org/10.1016/j.ajem.2022.11.012.
- For published clinical studies on pulse oximetry and the benefits of Masimo SET ® visit our website at http://www.masimo.com. Comparative studies include independent and objective studies composed of abstracts from scientific meetings and articles in peer-reviewed journals.
- Castillo A et al. Prevention of Retinopathy of Prematurity in Preterm Infants through Changes in Clinical Practice and SpO 2 Technology. Acta Paediatr. Feb. 2011;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;8. Jan.;338.
- Taenzer A 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 A et al. Postoperative Monitoring – The Dartmouth Experience. Newsletter der Anesthesia Patient Safety Foundation. Spring/Summer 2012.
- McGrath S 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.
- McGrath S et al. Inpatient Respiratory Arrest Associated With Sedative and Analgesic Medications: Impact of Continuous Monitoring on Patient Mortality and Severe Morbidity. J Patient Saf. 14 March 2020. DOI: 10.1097/PTS.0000000000000696.
- Estimate: Masimo data on file.
- http://health.usnews.com/health-care/best-hospitals/articles/best-hospitals-honor-roll-and-overview.
Forward-Looking Statements
This release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995. These forward-looking statements include, but are not limited to, statements regarding the potential effectiveness of Masimo SpHb®. These forward-looking statements are based on current expectations about future events affecting us and are subject to risks and uncertainties that are difficult to predict, many of which are beyond our control. Our actual results could differ materially and unfavorably from those projected in our forward-looking statements as a result of various risk factors. These include, but are not limited to, risks related to our assumptions about the repeatability of clinical trial results, risks related to our belief that Masimo’s unique technologies, including Masimo SpHb, contribute to positive clinical outcomes and patient safety, risks related to that the researchers’ conclusions and results may be inaccurate, risks associated with our belief that Masimo’s noninvasive medical breakthroughs are cost-effective solutions and offer unique benefits, risks associated with COVID-19, and other factors discussed in the “Risk Factors” of the most recent reports filed with the US Securities and Exchange Commission (SEC). These are available free of charge from 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 if our expectations will prove to be correct. All forward-looking statements contained 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 the present date. We undertake no obligation to update, revise, or clarify any of these statements or the “risk factors” contained in our most recent reports to the SEC, whether as a result of new information, future events or otherwise, except as required by applicable securities laws .
The source language in which the original text is published is the official and authorized version. Translations will be included for a better understanding. Only the language version that was originally published is legally valid. Therefore, compare translations with the original language version of the publication.
original version on businesswire.com regard:https://www.businesswire.com/news/home/20230108005060/de/
CONTACT: Media contact:
Fields
Evan Lamb
949-396-3376
elamb@masimo.com
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INDUSTRY KEYWORD: HEALTH MEDICAL DEVICES HOSPITALS HEALTH TECHNOLOGY GENERAL HEALTH CLINICAL TRIALS BIOTECHNOLOGY
SOURCE: Fields
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PUB: 01/09/2023 12:22 PM/DISC: 01/09/2023 12:22 PM
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