Healthy.io has received 510(k) clearance from the FDA of its test to screen for chronic kidney disease, the company said July 12.
The Minuteful Kidney test lets patients scan a urine sample with their smartphone camera to determine albumin to creatinine ratio and early signs of chronic kidney disease, according to a company news release.
This FDA clearance comes after the British National Health Service approved Healthy.io for at-home kidney tests. Minuteful Kidney is the first smartphone-powered test for albumin that has received FDA approval.