Nonin gets OK for OTC oximeter
By HME News Staff
Updated 11:01 AM CST, Tue December 3, 2024
PLYMOUTH, Minn. – Nonin Medical has secured U.S. Food and Drug Administration clearance for the TruO2 OTC, an over-the-counter fingertip pulse oximeter that’s accurate for patients of all skin colors. It’s the company’s first FDA-cleared, over-the-counter fingertip pulse oximeter. “Over the past several years, the U.S. market has been flooded with poor quality health and wellness-grade pulse oximeters which are not regulated by the FDA,” said John Hastings, CEO of Nonin Medical. “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. 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.” 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, the company says. 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, it says. The TruO2 OTC will be available directly to consumers on Amazon in December 2024 and from other online retailers soon after.
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