Nonin Medical has successfully obtained FDA 510(k) approval for its inaugural over-the-counter fingertip pulse oximeter, the TruO2 OTC. Starting this month, the device will be available for purchase on Amazon, with broader online retail availability expected soon.
The FDA has cautioned that pulse oximeters, which utilize red and infrared light to gauge blood oxygen levels and pulse rate, may yield dangerously imprecise readings in individuals with darker skin tones. However, Nonin, based in Plymouth, Minnesota, asserts that its pulse oximetry technology has shown robust performance in independent testing of its Onyx Vantage 9590 model, intended for professional use. The new TruO2 OTC continues Nonin’s tradition of crafting reliable and precise pulse oximetry devices.
John Hastings, CEO of Nonin Medical, indicated in a statement issued to MassDevice prior to the official announcement that “over recent years, the U.S. market has been inundated with subpar, health-and-wellness-grade pulse oximeters lacking FDA regulation. This situation often leads to a bewildering and frustrating experience for consumers, especially those with conditions like COPD or asthma, who require an accurate, reliable solution for home use.”
Hastings further added, “The introduction of TruO2 OTC enables consumers to access medical-grade technology designed for accurate readings across all skin tones. We anticipate this will significantly improve the quality and dependability of home-based monitoring, ultimately leading to better health results for everyone.”
In a separate announcement in September, Masimo revealed that its MightySat Medical fingertip pulse oximeter was the first to attain FDA clearance for over-the-counter applications. Like Nonin’s TruO2, Masimo’s device also demonstrated impressive outcomes in independent testing.