Industry Bulletins | July 27, 2022
FDA Approves Healthy.io Smartphone Kidney Function Test
The U.S. Food and Drug Administration (FDA) granted 510(k) clearance to Healthy.io for its Minuteful Kidney test, a smartphone application that is used to assess a urine sample to detect proteins associated with chronic kidney disease (CKD). The app uses artificial intelligence to assess the standard albumin-to-creatinine ratio (ACR) of a urine sample. ACR is an early indicator of kidney damage.
The Healthy.io Minuteful Kidney test can be used with all current iOS and Android smartphone devices. By adopting and covering this technology, health plans can screen consumers at scale to detect members with . . .