Healthy.io, a technology company, announced its product Minuteful Kidney has received 510(k) clearance from the FDA.
According to the press release, Minuteful Kidney is a smartphone-based home kidney test and is the first technology of its kind to receive FDA clearance. Using an app and backend server, Minuteful Kidney measures patients’ albumin-to-creatinine ratio with a smartphone camera.
For interested users, Healthy.io will mail a test kit to patients. The kit includes a cup to urinate in and urine test dipsticks. Once the dipstick is matched to the kit’s color board, patients