Nonin Medical
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. Dedicated to providing accurate readings on adults across all skin tones, the company says the device empowers patients and their healthcare professionals with accurate measurements, allowing them to make informed healthcare decisions.
The vast majority of pulse oximeters sold directly to consumers are classified as 'health and wellness devices' and are not required to meet the stringent 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, OTC devices are classified as 'medical devices' and are regulated by the FDA, ensuring medical-grade technology is just as conveniently accessible to consumers as health and wellness products.
“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,” said John Hastings, CEO of Nonin Medical.
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.
Nonin has a proven record of developing highly accurate pulse oximetry devices and has always placed a high priority on accuracy across skin pigmentation in its product development. In multiple independent studies, Nonin Medical says its 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 legacy of developing durable and accurate pulse oximetry devices. This mission started with the company’s founder Phil Isaacson, the original maker of the fingertip pulse oximeter.
“For decades, we have pioneered advancements in pulse oximetry, making healthcare accessible for diverse populations, in collaboration with other organisations, 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,” concluded Hastings.
