FDA Clears Healthy.io’s Smartphone-Based Test For Early-Stage Kidney Disease

On July 6, 2022, the U.S. Food and Drug Administration (FDA) granted 510(k) clearance for the Mindful Kidney smartphone-powered mobile application developed by Healthy.io. The Minuteful Kidney app provides consumers with a reliable way to test their kidney function at home and obtain clinical grade results. The application is cleared for use on all current iOS and Android devices and is available only by prescription.

The test is a home-use urine analysis test system that measures albumin and creatinine in urine and calculates the albumin-creatinine ratio (ACR), a measure for detecting chronic kidney disease . . .