Safe Heart USA claims that its pulse oximeter proved to be 100% more accurate than comparable devices in an analysis by the FDA.
Atlanta-based Safe Heart’s iOX smartphone pulse oximeter combines hardware and software technology to accommodate individual skin tone and blood flow, according to a news release.
The iOX is powered through the audio or USB cable connected to a smartphone, making it the first of its kind to receive FDA approval. The iOX app which accompanies it is free on the Google Play and Apple App Store and stores the user’s vital signs data, making them capable of being shared if the user chooses to do so.
News of the capable device comes after, just last week, reports cited data showing that pulse oximeters, a useful tool for measuring oxygenation issues and elevated heart rates — potential signs of COVID-19 infection — are reportedly more error-prone with Black patients.
Masimo founder & CEO Joe Kiani told MassDevice via email that skin pigmentation has represented a challenge in pulse oximetry, with dark pigmentation sometimes resulting in overestimation. Masimo (NSDQ:MASI), a prominent maker of pulse oximeters, has also reported far fewer discrepancies related to skin pigmentation than competitors.
The FDA approved the iOX pulse oximeter as a Class II medical device for use in adult patients in clinical institutions and home environments on Nov. 27, Safe Heart said.
“The iOX’s 4096 levels of light intensity allow any patient with low perfusion (low blood flow) or darker skin tone to have accurate readings on the iOX,” Safe Heart USA founder Yale Zhang said in the release. “Unlike standard pulse oximeters with a fixed setting, this automatic calibration, taking place at a rate of up to 240 times per second, is a feature unique to the iOX, resulting in highly accurate readings of +/- 1% oxygen saturation for all users.”