epocrates

FDA clears Nonin's TruO2 OTC pulse oximeter for all skin tones

December 4, 2024

Nonin Medical has received FDA clearance for its TruO2 OTC fingertip pulse oximeter, which provides accurate blood oxygen readings for patients of all skin tones.

According to the manufacturer’s press release, the device addresses disparities in pulse oximetry accuracy that have historically affected patients with darker skin. By offering medical-grade technology over-the-counter, Nonin’s CEO, John Hastings, said the company aims to enhance home-based health monitoring and improve health outcomes for all patients. “The availability of TruO2 OTC now provides all consumers with access to equitable, medical-grade technology that is designed for accuracy across all skin tones. We believe this will significantly enhance the quality and reliability of home-based monitoring, leading to better health outcomes for everyone,” said Hastings.

The TruO2 OTC will be available on Amazon in December 2024 and other online retailers shortly thereafter.

Sources:

Nonin Medical. (2024, December 2). Nonin Medical secures FDA clearance for its over-the-counter fingertip pulse oximeter, accurate for patients of all skin colors. [Press release]. https://www.nonin.com/nonin-medical-secures-fda-clearance-for-its-over-the-counter-fingertip-pulse-oximeter-accurate-for-patients-of-all-skin-colors/

U.S. Food and Drug Administration. (2024, December 2). 510(k) Premarket Notification: Nonin OTC Pulse Oximeter Model 3250. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K211498