CIRCUL™ pulse oximetry wearable technology has a statistically significant correlation in providing stable oxygen saturation values in individuals with dark pigments
PR Newswire-PR Newswire / Manhattan Beach, California, February 23, 2021, BodiMetrics, a global leader in medical ring sensor technology, today announced the results of a clinical study that validates its CIRCUL™ ring pulse oximeter The efficacy and reliability of pigmentation participants in the dark, positioning it as an excellent continuous blood oxygen monitoring device for ethnic minorities in the United States and the world. A recent article published in the New England Journal of Medicine pointed out that black patients are at higher risk due to hypoxemia and subsequent adverse health effects. Recently, someone has evaluated the reliability of pulse oximeters. , This is a non-invasive device for evaluating heart rate and oxygen-saturated hemoglobin. Compared with white patients, the measurement accuracy of pulse oximeter is poor.
The CIRCUL™Ring clinical validation study conducted at Tongde Hospital in Zhejiang Province, China compared the simultaneous measurement results of the CIRCUL™Ring and arterial blood gas (ABG) tests of 12 individuals (4 blacks, approximately 33% of the total enrollment). The ABG test result is considered to be the most accurate way to measure the oxygenation level in the blood, but it is more invasive due to the need for venous blood sampling. For blacks, the results of 100 oxygen saturation measurements taken from the CIRCUL™ ring have an excellent correlation with the data obtained at the same time as the ABG test (the oxygen saturation range is 100% to 70%). The average difference between CIRCUL™ and ABG values is only 1.06%.
The ongoing COVID pandemic highlights the importance of monitoring personal blood oxygenation (SpO2) before, during and after exposure or infection. On January 25, 2021, Senator Elizabeth Warren (Elizabeth Warren (D-Mass.), Cory Booker (DN.J.) and Ron Wyden) (D-Ore.) This was emphasized in a letter to the U.S. Food and Drug Administration (FDA). A review of the accuracy of pulse oximeters for patients and consumers of different races. The letter cited several items. Studies have shown that the accuracy of pulse oximeters for black patients is lower than that of white patients, which is likely to be the result of racial bias in the calibration of the device. One such study found that low blood oxygenation levels are Black patients are three times more likely to be undetected. The authors of the study further summarized their findings “highlight the continuing need to understand and correct racial bias in pulse oximetry and other forms of medical technology.”
An oversight letter to the FDA on January 25, 2021, “Senators Warren, Booker, and Wyden urge the FDA to address concerns about dangerous pulse oximeter errors in colored patients”, https://www.warren.senate.gov /oversight/letters/ Senators Warren Booker and Wooden urged the FDA to address the issue of inaccurate pulse oximeters for patients with dangerous colors
BodiMetrics is committed to developing and providing innovative equipment, such as CIRCUL rings, applications and algorithms, which can provide remote diagnosis and monitoring functions to expand the scope of care, promote continued health and improve self-management and third-party auxiliary care procedures Compliance with treatment regimens such as congestive heart failure (CHF), asthma, COPD, sleep apnea, and family health.
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Post time: Mar-11-2021