Masimo (NASDAQ: MASI) today announced the publication of a peer-reviewed study regarding Masimo SET pulse oximetry performance in varying skin pigmentation in the
The retrospective trial, 'Racial effects on Masimo pulse oximetry: a laboratory study,' by Drs.
For this newly published study
The data were analyzed to determine the bias (mean difference in paired SpO2 and SaO2 samples), precision (standard deviation of the difference), and accuracy (root mean squared error, ARMS) for both groups. A negative bias of 0.20% was found for Black subjects, compared to 0.05% for White subjects. This difference of 0.15% (p < 0.001) is not clinically significant and the values are numerically indistinguishable because the SpO2 display resolution is 1% on commercially available pulse oximeters (both from Masimo and other manufacturers). The investigators also found a precision of 1.40% for Black subjects and 1.35% for White subjects. Accuracy (ARMS) was 1.42% for Black subjects and 1.35% for White subjects. These results are consistent with the accuracy specifications of RD SET sensors (1.5% accuracy ARMS), which are twice as good as the current FDA clearance thresholds for medical-grade pulse oximeters (3.0% accuracy ARMS).
In discussing their findings, Drs. Barker and Wilson describe how Masimo SET accounts for skin pigmentation when measuring SpO2. 'The absence of racial bias, and highly accurate overall performance exhibited by Masimo SET pulse oximetry can be logically explained by Masimo's engineering design and testing paradigm. ... Conventional pulse oximetry uses the standard red over infrared algorithm to provide SpO2, while Masimo SET uses that conventional algorithm along with four additional signal processing engines that all run in parallel. These signal processing systems allow the distinction between arterial and venous signal during motion and low perfusion by identifying and isolating the non-arterial and venous noise SpO2 from the true arterial SpO2 components in the signal. These multiple signal processing engines work together to overcome limitations of each independent method. This advanced technique allows for a more accurate picture of the pulsatile (arterial) signal and significantly reduces the impact of static absorbers such as skin pigment, bone density, and tissue thickness (e.g., finger, toe, or earlobe). Finally, the Masimo SET SpO2 algorithm is calibrated and then validated using nearly equal numbers of dark and light-skinned subjects.'
Drs. Barker and Wilson summarized, 'In conclusion, this retrospective study of healthy human volunteers monitored with Masimo RD SET pulse oximeter sensors showed an absence of clinically significant differences in accuracy between Black and White subjects.' The authors suggested that additional prospective clinical studies should be conducted to validate their results in critically ill patients utilizing Masimo SET pulse oximeters and those from other manufacturers.
ARMS accuracy is a statistical calculation of the difference between device measurements and reference measurements. Approximately two-thirds of the device measurements fell within +/- ARMS of the reference measurements in a controlled study.
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
ORi, RPVi, and Radius VSM have not received FDA 510(k) clearance and are not available for sale in
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 SET and RD SET, and Masimo's plan to conduct additional studies on the accuracy of Masimo SET and RD SETon Black people and White people ('Additional Studies'). 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 SET and RD SET, contribute to positive clinical outcomes and patient safety; risks that Masimo fails to conduct Additional Studies as planned; 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
Contact:
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Email: elamb@masimo.com
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