The US Food and Drug Administration has granted BodiMetrics 510k clearance for its circul pro ring as a pulse oximeter.
The circul pro ring is able to accurately measure blood oxygen levels in people with any skin tone, according to a release from the company. The device’s accuracy in measuring oximetry levels on dark skin pigmentation was examined in a peer-reviewed publication in the Mayo Clinic Clinical Proceedings, Digital Health, which found the oximeter “seems to be independent of skin tone, perhaps because measurements are made on the palmar surface of the digit, where there is generally less pigment.”
“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, in a release.
The wearable device, powered by a rechargeable lithium battery, boasts a patented spring-loaded design and LED sensors. The ring’s stability and sensor positioning on the underbelly of the finger, the palmar surface, make it possible to collect continuous SpO2 readings for up to 12 hours in both home and hospital settings.
“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,” says Meir Kryger, MD, professor emeritus of the Yale School of Medicine, in a release.
Photo caption: Circul pro ring
Photo credit: BodiMetrics
