Nonin Medical Gains FDA-Clearance for OTC Fingertip Pulse Oximeter

Nonin Medical, a leading global manufacturer of wearable and noninvasive medical monitoring devices, has announced its first over-the-counter (OTC) FDA-cleared fingertip pulse oximeter – the TruO2 OTC. The device provides accurate readings on adults across all skin tones.

“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, John Hastings, CEO of Nonin Medical.

The majority of pulse oximeters sold to consumers are not required to meet FDA requirements for medical devices are classified as “health and wellness devices,” and are not intended to diagnose, prevent, or treat disease. 

On the other hand, OTC devices are regulated by the FDA to ensure that medical-grade technology is just as conveniently accessible to consumers as health and wellness products.

This device was made in response to 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. 

“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,” Hastings added.

In multiple independent studies, Nonin Medical’s pulse oximetry technology outperformed low-cost oximeters and other medical-grade oximeters and exceeded FDA requirements. 

The TruO2 OTC fingertip pulse oximeter builds on Nonin’s legacy pulse oximetry devices. 

“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 concluded.

The TruO2 OTC will be available directly to consumers on Amazon in December 2024 and other online retailers soon after.