MANHATTAN BEACH, Calif.,
Feb. 23, 2021 /PRNewswire/ --
BodiMetrics, the global leader in medical ring sensor
technology, today announced the results of a clinical study that
validates the efficacy and reliability of their CIRCUL™ Ring
pulse oximeter in dark-pigmented participants, positioning it as a
superior continuous blood oxygen monitoring device for minority
populations in the US and globally. The reliability of pulse
oximeters, noninvasive devices for assessing heart rate and
oxygen-saturated hemoglobin, have recently been critiqued following
an article published in the New England Journal of Medicine that
suggested Black patients were at higher risk for hypoxemia and
subsequent negative health impacts due to less accurate pulse
oximeter measurements relative to those of white patients.
The CIRCUL™ Ring clinical validation study, conducted at the
Tongde Hospital of Zhejiang
Province, China, compared
simultaneous measurements for the CIRCUL™ Ring and an arterial
blood gas (ABG) test from 12 individuals (4 Black, ~33% of total
enrollment). ABG test results are considered to be the most
accurate method for measuring blood oxygenation levels but are more
invasive due to the necessity of intravenous blood sampling. For
Black individuals, 100 oxygen saturation measurements from the
CIRCUL™ Ring showed excellent correlation with data obtained
simultaneously from ABG testing for oxygen saturations ranging from
100% to 70%. The mean difference between CIRCUL™ and ABG values was
only 1.06%.
The ongoing COVID pandemic highlights the importance of
monitoring individuals' blood oxygenation (SpO2) before, during,
and after exposure or infection. This was emphasized in a
January 25, 2021 letter to the US
Food and Drug Administration (FDA) by Senators Elizabeth Warren (D-Mass.), Cory Booker (D-N.J.), and Ron Wyden (D-Ore.) requesting a review of the
accuracy of pulse oximeters across racially diverse patients and
consumers. The letter cites several studies suggesting pulse
oximeters provide less accurate measurements for Black patients
when compared to white patients, likely the result of racial bias
in device calibration. One such study found that low levels of
blood oxygenation were up to three times as likely to go undetected
in Black patients. The authors of that study further conclude their
findings "highlight an ongoing need to understand and correct
racial bias in pulse oximetry and other forms of medical
technology."
1 Oversight Letter to FDA dated January 25, 2021, "Senators Warren, Booker and
Wyden Urge FDA to Address Concerns about Dangerous Pulse Oximeter
Inaccuracies for Patients of Color",
https://www.warren.senate.gov/oversight/letters/senators-warren-booker-and-wyden-urge-fda-to-address-concerns-about-dangerous-pulse-oximeter-inaccuracies-for-patients-of-color
The CIRCUL™ Ring is currently under review by the United States
Food and Drug Administration for Emergency Use Authorization. The
CIRCUL™ Ring should not be used as the sole determinant in any
therapy, diagnosis, or treatment of patients.
CIRCUL is registered trademark of BodiMetrics,
LLC.ABOUT BODIMETRICS:
BodiMetrics is dedicated to developing and delivering innovative
devices, such as the CIRCUL ring, applications and algorithms that
provide remote diagnostics and monitoring to extend care, foster
ongoing wellness and improve adherence to treatment protocols in
self-managed and third-party assisted care programs, such as
congestive heart failure (CHF), asthma, COPD, sleep apnea, and
family wellness.
Visit www.bodimetrics.com or contact them at (844) 744-8800 for
additional information.
Follow them on Facebook and Twitter.
This press release was issued through 24-7PressRelease.com. For
further information, visit http://www.24-7pressrelease.com.
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content:http://www.prnewswire.com/news-releases/clinical-validation-in-dark-pigmented-individuals-finds-circul-pulse-oximetry-ring-provides-reliable-oxygen-saturation-readings-addressing-potential-discrimination-in-traditional-pulse-oximeters-301233851.html
SOURCE BodiMetrics