Significant FDA Clearance Given to circul™ Pro Ring After Lengthy Evaluation

LOS ANGELES, CA, USA, September 7, 2023/EINPresswire.com/ -- BodiMetrics is proud to announce that its circul™ pro Ring has received FDA clearance as a pulse oximeter. This is a significant achievement, especially given the increased focus on oximetry in non-Caucasian populations by the FDA and the medical community at large. The circul™ pro Ring's patented and revolutionary form factor and LED technology make it uniquely designed to accurately measure blood oxygen level on people with any skin tone. With this clearance, BodiMetrics is poised to revolutionize the pulse oximetry market and provide accurate and reliable readings for patients of all ethnicities.

“With the recent scrutiny and clinical results highlighting the inaccuracy of some oximeters in darker pigmented skin, the demand for a higher level of performance is greater than ever. The design, accuracy and reliability of the circul™ pro Ring is a true testament to its exceptional performance. BodiMetrics is pleased to be able to help address the inherent health inequities resulting from existing products and is proud to have achieved this accomplishment,” says Neil Friedman, COO of Bodimetrics.

Introducing the circul™ pro Ring, a state-of-the-art wearable device powered by a rechargeable lithium battery. Designed to fit snugly on a finger, this innovative ring boasts a patented spring-loaded design and LED sensors that deliver documented accuracy and performance. The ring's stability and sensor positioning on the underbelly of the finger, or palmar surface, make it possible to collect continuous SpO2 readings for up to 12 hours in both home and hospital settings, regardless of skin tone.

BodiMetrics' CEO, Mark Goettling, believes “this accomplishment validates over five years of hard work in product design, AI development, clinical trials, and market testing with the FDA Clearance of the circul™ pro Ring. Unlike other wearables in the market that cater primarily to healthy consumers, the circul™ pro Ring is purpose-built for individuals who prioritize managing their health and being an active partner with their health care provider. The ring has already been adopted by leading healthcare providers and academic institutions, proving its efficacy in clinical applications. BodiMetrics is proud to offer a medical-grade wearable that empowers individuals to take control of their health.”

The device's accuracy in measuring oximetry levels on dark skin pigmentation has been reinforced by a recent peer-reviewed publication in the Mayo Clinic Clinical Proceedings, Digital Health, which confirms that the circul™ pro Ring's oximetry accuracy is independent of skin tone. This clinical data is a significant breakthrough as it addresses a long-standing issue in the accurate measurement of oximetry levels in people with dark skin pigment. The Mayo Clinic article highlights the circul™ pro Ring's ability to deliver reliable and accurate results, regardless of skin tone, making it a valuable tool for healthcare professionals worldwide.

The global COVID pandemic has highlighted the critical need for accurate and continuous monitoring of blood oxygenation levels, especially for those with chronic respiratory conditions such as asthma, COPD, pulmonary fibrosis, sleep apnea, and other related diseases.

Dr. Meir Kryger, professor emeritus of the Yale School of Medicine succinctly sums up why accurate oximetry is so important: “Having normal levels of oxygen in the blood is absolutely vital for optimal health. Some oximeters may be inaccurate in people with dark skin pigment. Not only is the circul™ pro Ring oximeter FDA cleared, it has been shown in research studies to be accurate on people with all skin tones.”

Referenced Media News:
Racial Bias in Pulse Oximetry Measurement: NEJM
https://www.nejm.org/doi/10.1056/NEJMc2029240

Racial and Ethnic Discrepancy in Pulse Oximetry: JAMA
https://shorturl.at/aduC7

Inaccuracies in Pulse Oximeters May Delay Covid-19 Treatment for Nonwhite Patients: HUB-John’s Hopkins U.
https://hub.jhu.edu/2022/07/18/inaccurate-pulse-oximeters-delayed-covid-treatment-for-nonwhite-patients/

Validation of a Smart Ring Oximeter in Individuals With Dark Skin Pigment Mayo Clinic Proceedings:
Digital Health. Vol. 1. Issue 3. p357–365. Published online: July 28, 2023
https://www.mcpdigitalhealth.org/article/S2949-7612(23)00057-3/fulltext

About BodiMetrics
BodiMetrics is dedicated to empowering consumers and patients alike with products, services, and solutions that will allow them to take charge of their healthcare, lower overall costs, and improve their well-being. All BodiMetrics products are tested by independent third-party labs to clinical standards as well, where indicated, approved by the FDA. For more information, visit https://circul.health/ by https://bodimetrics.com

Don W Klosterman
Klosterman Marketing Communication
+1 714-501-5949
donklos at gmail dot com
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