FDA grants clearance to smartphone-based home urinalysis test
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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 then take a picture of the dipstick using the app. The results are immediately displayed and shared with the patient’s doctor.
“Millions of Americans are living with kidney disease, yet many don’t know they have the condition. An albumin test is required for proper diagnosis, and an important tool to monitor kidney health for those at risk,” George Bakris, MD, director of the comprehensive hypertension center at the University of Chicago and the American Diabetes Association, said in the press release. “Healthy.io has provided an easy way to provide patients and clinicians with potentially life-saving information.”
This clearance follows United Kingdom acceptance of Minuteful Kidney into the National Health Service.
Reference:
Healthy.io services. https://healthy.io/services/kidney Accessed: July 12, 2022.
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