Study Evaluates Performance of Masimo iSpO2® Rx Smart Device-Paired Pulse Oximeter in Screening Newborns for Critical Congenital Heart Disease
CCHD affects approximately 2.5 to 3 newborns per 1000 live births2 and requires intervention soon after birth to prevent significant morbidity or mortality; later detection in infants also increases the risk of brain damage.3 In the study, Dr. Huizing and colleagues sought to evaluate the accuracy of iSpO2 Rx because of increasing trends toward out-of-hospital births and concerns about the costs of CCHD screening implementation in low-resource settings. The researchers surmised that a portable, low-cost pulse oximeter may be more practical in such settings than standalone hospital devices.
The researchers enrolled 201 infants in the study. CCHD screening was
conducted 12-24 hours after birth by two independent teams, who were
blinded to the other team’s results. Each team took both preductal
(right-hand) and postductal (either foot) SpO2 measurements
to establish whether an infant passed, failed, or needed a repeat
screening. One team measured oxygen saturation using a Masimo Radical-7®
Pulse CO-Oximeter® equipped with disposable Masimo LNCS®
sensors. The other team used a
Applying Bland-Altman analysis to the preductal SpO2 values of the 201 screened infants, with Radical-7 as the reference device, the researchers calculated a mean bias of -0.08% ± standard deviation of 1.76%, with limits of agreement of -3.52% and 3.36%. For postductal SpO2 values, they calculated a mean bias of -0.11% ± standard deviation of 1.68%, with limits of agreement of -3.41% and 3.18%.
In addition, to evaluate the ability of iSpO2 Rx to measure low oxygen saturation, the researchers also enrolled a group of 12 infants admitted to the neonatal intensive care unit (NICU) with SpO2 lower than 95%. SpO2 was continuously monitored for 10 minutes, with readings recorded once per minute, and with one foot connected to the iSpO2 Rx and the other to a Philips IntelliVue MP70 monitor equipped with Masimo SET® technology. Using the Philips monitor as the reference device, the researchers calculated a mean bias of 0.01% ± standard deviation of 1.74%, with limits of agreement of -3.42% and 3.43%.
The researchers concluded that, “Our data suggest that CCHD screening
The device used in this study is iSpO2 Rx. The study did not use the iSpO2, which is intended as an exercise and wellness product and is not available for use on neonates. iSpO2 is not intended for CCHD screening or any other medical use.
iSpO2 Rx does not have 510(k) clearance and is not available
for sale in
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- Huizing M, Villamor-Martinez-E, Chavagne I, Vanagt W, Spaanderman M, and Villamor E. Reliability and Validity of a Smartphone-Paired Pulse Oximeter for Screening of Critical Congenital Heart Defects in Newborns. Neonatology. 2017;112:324–329. DOI: 10.1159/000477294.
- Hoffman JL et al. The incidence of congenital heart disease. J Am Coll Cardiol. 2002 Jun 19;39(12):1890-1900.
2011 Legislative Report;
State of Maryland, Department of Health and Mental Hygience, State Advisory Council on Hereditary and Congenital Disorders. Recommendations on Implementation of Screening for Critical Congenital Heart Disease in Newborns. Page 7.
ORi has not received
*The use of the trademark Patient SafetyNet is under license from
- 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.
Masimodata 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 Radical-7® Pulse CO-Oximeter®
and iSpO2® Rx. 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
Evan Lamb, 949-396-3376