Masimo SpHb on the Handheld Masimo Rad-67� Demonstrated Acceptable Accuracy and Excellent Correlation with Laboratory Hemoglobin
NEUCHATEL, Switzerland–(BUSINESS WIRE)–Masimo (NASDAQ: MASI) today announced the results of a prospective study published in the American Journal of Emergency Medicine in which Dr. Zohair Ahmed Ali Al Aseri and colleagues at King Saud University Medical City and Dar Al Uloom University (Riyadh, Saudi Arabia) evaluated the performance of noninvasive spot-check hemoglobin measurement with Masimo SpHb® on emergency department (ED) patients. The researchers found that SpHb provided acceptable accuracy and excellent correlation with their invasive laboratory measurements and offers an easy, quick, feasible, cheap, and accurate solution for Hb measurement in the ED.1
Noting that invasive blood hemoglobin measurement, while an important step in the management of blood loss, has drawbacks such as consumption of valuable time, phlebotomy-induced anemia, pain, infection, and more involvement of human resources and equipment, the authors sought to evaluate whether a noninvasive modality might offer similarly accurate results while mitigating some of these factors. To compare noninvasive and invasive measurements, they enrolled 650 patients (age > 14 years) who visited the EDs of two hospitals within King Saud University Medical City between March and May 2022 and needed complete blood count measurements. Hemoglobin was noninvasively measured (SpHb) using the Masimo Rad-67® handheld Pulse CO-Oximeter® with the DCI®-mini fingertip sensor. Simultaneously, blood samples were collected and analyzed at the time of collection (LabHb) using their automated analyzer, a UniCel DxH 800 Coulter Cellular Analysis System.
The researchers found a highly significant correlation between SpHb and LabHb (Pearson correlation coefficient = 0.812, p < 0.01). Bland-Altman analysis revealed low mean bias 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.
The researchers concluded that noninvasive hemoglobin (SpHb) measurement showed acceptable accuracy and excellent correlation with LabHb and provided an easy, quick, feasible, cheap, and accurate solution for Hb measurement in the ED. Further research is required to study its effects on patient outcomes and blood transfusion and time and cost effectiveness.
SpHb is not intended to replace laboratory blood testing. Clinical decisions regarding red blood cell transfusions should be based on the clinicians judgment considering, among other factors, patient condition, continuous SpHb monitoring, and laboratory diagnostic tests using blood samples.
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About Masimo
Masimo (NASDAQ: MASI) is a global medical technology company that develops and produces a wide array of industry-leading monitoring technologies, including innovative measurements, sensors, patient monitors, and 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 mission is to improve life, improve patient outcomes, and reduce the cost of care. Masimo SET® Measure-through Motion and Low Perfusion pulse oximetry, introduced in 1995, has been shown in over 100 independent and objective studies to outperform other pulse oximetry technologies.2 Masimo SET® has also been shown to help clinicians reduce severe retinopathy of prematurity in neonates,3 improve CCHD screening in newborns,4 and, when used for continuous monitoring with Masimo Patient SafetyNet in post-surgical wards, reduce rapid response team activations, ICU transfers, 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 at 9 of the top 10 hospitals as ranked in the 2022-23 U.S. News and World Report Best Hospitals Honor Roll.10 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®), RPVi (rainbow® PVi), and Oxygen Reserve Index (ORi). In 2013, Masimo introduced the Root® Patient Monitoring and Connectivity Platform, built from the ground up to be as flexible and expandable as possible to facilitate the addition of other Masimo and third-party monitoring technologies; key Masimo additions include Next Generation SedLine® Brain Function Monitoring, O3® Regional Oximetry, and ISA Capnography with NomoLine® sampling lines. Masimos family of continuous and spot-check monitoring Pulse CO-Oximeters® includes devices designed for use in a variety of clinical and non-clinical scenarios, including tetherless, wearable technology, such as Radius-7®, Radius PPG®, and Radius VSM, portable devices like Rad-67®, fingertip pulse oximeters like MightySat® Rx, and devices available for use both in the hospital and at home, such as Rad-97®. Masimo hospital and home automation and connectivity solutions are centered around the Masimo Hospital Automation platform, and include Iris® Gateway, iSirona, Patient SafetyNet, Replica®, Halo ION®, UniView®, UniView :60, and Masimo SafetyNet®. Its growing portfolio of health and wellness solutions includes Radius Tº® and the Masimo W1 watch. Additional information about Masimo and its products may be found at www.masimo.com. Published clinical studies on Masimo products can be found at www.masimo.com/evidence/featured-studies/feature/.
ORi, RPVi, and Radius VSM have not received FDA 510(k) clearance and are not available for sale in the United States. The use of the trademark Patient SafetyNet is under license from University HealthSystem Consortium.
References
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 SpHb®. 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 SpHb, contribute to positive clinical outcomes and patient safety; risks that the researchers conclusions and findings may be inaccurate; risks related to our belief that Masimo noninvasive medical breakthroughs provide cost-effective solutions and unique advantages; risks related to COVID-19; 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.
Contacts
Media Contact:
Masimo
Evan Lamb
949-396-3376
elamb@masimo.com
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