The FDA has granted 510(k) clearance for Nonin TruO2 OTC over-the-counter fingertip pulse oximeter designed to provide accurate blood oxygen readings across all skin tones.
RT’s Three Key Takeaways:
- FDA-Cleared Medical Device: The FDA has granted 510(k) clearance for Nonin Medical’s TruO2 OTC fingertip pulse oximeter, a medical-grade device designed for accurate blood oxygen readings across all skin tones.
- Addressing Disparities: This clearance addresses concerns about disparities in pulse oximetry accuracy, particularly for patients with darker skin tones, as highlighted during the COVID-19 pandemic.
- Validated Accuracy: Independent studies have demonstrated the accuracy of Nonin’s pulse oximetry compared to other low-cost and medical-grade oximeters.
The US Food and Drug Administration (FDA) has granted Nonin Medical 510(k) clearance for its over-the-counter fingertip pulse oximeter, the TruO2 OTC, designed for accuracy across all skin tones.
The vast majority of pulse oximeters sold directly to consumers are classified as “health and wellness devices” and are not required to meet the requirements of the FDA for medical devices. This is because health and wellness products are only meant to promote a healthy lifestyle. They do not have any medical claims and are not intended to diagnose, treat, or prevent disease. In fact, several low-cost devices have shown significant errors in estimating blood oxygen saturation.
By contrast, over-the-counter devices are classified as “medical devices” and are regulated by the FDA, ensuring medical-grade technology is accessible to consumers.
“Over the past several years, the US market has been flooded with poor quality health and wellness-grade pulse oximeters which are not regulated by the FDA. This creates a confusing and frustrating experience for consumers, including those with conditions like COPD or asthma, seeking an accurate, equitable, and durable solution for home use,” says John Hastings, CEO of Nonin Medical, in a release.
Challenge With Accuracy Across Skin. Tones
The challenge with accuracy has been further compounded by the well-documented shortcomings of pulse oximeters for patients with dark skin. Data collected during the COVID-19 pandemic demonstrated that pulse oximeters missed hypoxia in patients with darker skin tones, leading to unequal access to healthcare and putting patients at risk of serious long-term health consequences. According to research, people with dark skin tones are 32% more likely to have their blood oxygen levels overestimated than white 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,” says Hastings in a release.
In multiple independent studies, Nonin Medical’s pulse oximetry technology has outperformed low-cost oximeters and other medical-grade oximeters—and even exceeded FDA requirements. Two studies, one conducted in 2005 on three devices and another conducted in 2024 on 11 devices, demonstrated that Nonin’s pulse oximeter outperformed other devices, with participants in both studies representing a range of skin tones.
The TruO2 OTC fingertip pulse oximeter builds on Nonin’s development of accurate pulse oximetry devices, according to a release from the company. The device works by transmitting radiation at a known wavelength through blood and measures the blood oxygen saturation based on the amount of reflected or scattered radiation.
“For decades, we have pioneered advancements in pulse oximetry, making healthcare accessible for diverse populations, in collaboration with other organizations, including other manufacturers and the FDA. We are deeply committed to ensuring better health outcomes for everyone and are excited to launch the TruO2 OTC to further ensure access to equitable health care,” Hastings says in a release.
The TruO2 OTC will be available directly to consumers on Amazon in December 2024 and from other online retailers soon after.
Photo caption: TruO2 OTC
Photo credit: Nonin Medical
