The device will be available for purchase on Amazon.com this month, followed by availability through other online retailers.
The FDA has warned that pulse oximeters — which beam red and infrared light into a patient’s tissue to measure their blood oxygen saturation and pulse rate — can deliver dangerously inaccurate readings in people with darker skin.
But Plymouth, Minnesota–based Nonin said the pulse oximetry technology has performed well in independent testing of its professional-use Onyx Vantage 9590, and the new TruO2 OTC device “builds on Nonin‘s legacy of developing durable and accurate pulse oximetry devices.”
“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,” Nonin Medical CEO John Hastings said in a statement shared with MassDevice ahead of the official announcement. “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,” he continued. “We believe this will significantly enhance the quality and reliability of home-based monitoring, leading to better health outcomes for everyone.
In September, Masimo announced its MightySat Medical fingertip pulse oximeter was the first to win FDA clearance for over-the-counter use. That device also performed well in the independent testing cited by Nonin.
