Clinical Validation in Dark Pigmented Individuals Finds CIRCUL™ Pulse Oximetry Ring Provides Reliable Oxygen Saturation Readings

Regarding conversations and articles about the problem with Oximeters and Skin Pigments.

BodiMetrics has  data that CIRCUL is not impacted by this problem

Chronology of what has happened over the last few month in the news regarded this subject:


Dec 17, 2020

Article published in NEJM

https://www.nejm.org/doi/pdf/10.1056/NEJMc2029240?articleTools=true

Dec 22, 2020

New York Times does an article on Oximeters and Pigment problems

https://www.nytimes.com/2020/12/22/health/oximeters-covid-black-patients.html

Jan 07, 2021

NYC should be commended for being the first city to try to get their hands around pre and post COVID-19.

Unfortunately the attempt needs to be refined

  1. Episodic measurements will not accomplish what they are trying to accomplish They must have continuous blood oxygen
  2. Pigment problems the majority of people who will be receiving oximeters are people of color

NYC Guidance above Circul Covid 19 Pulse oximeters

Jan 25, 2021

Senators Warren, Booker and Wyden write a letter to the FDA concerning Non  Intended  racial discrimination from pulse oximeters.

https://www.warren.senate.gov/imo/media/doc/2020.01.25%20Letter%20to%20FDA%20re%20Bias%20in%20Pulse%20Oximetry%20Measurements.pdf

February 10, 2021

William Maisel from FDA is quoted in article from Stats

“We agree that individuals with dark pigmentation — particularly if they’re relying on oximeters in the home — may get false or inaccurate readings, and that’s important for them to be aware of,” William Maisel, director of the office of product evaluation and quality at FDA’s Center for Devices and Radiological Health, told STAT.

https://www.statnews.com/2021/02/10/pulse-oximeters-racial-disparities/

February 19, 2021

FDA comes out with notice regarding safety and accuracy of oximeters

https://www.fda.gov/medical-devices/safety-communications/pulse-oximeter-accuracy-and-limitations-fda-safety-communication

February 22, 2021

CNN reports about the problem with people of Color be misdiagnosed due to improper measurements from Oximeters

February 23, 2021

BodiMetrics comes out with Press Release regarding findings of effectiveness of Circul for people of Color

https://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

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.

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