Following its adoption by the UK’s National Health Service (NHS), the Minuteful Kidney test from Healthy.io has received 510(k) clearance from the U.S. Food and Drug Administration (FDA). It’s a smartphone-based ACR test that looks for albumin, a protein that’s made by the liver that can be measured as particles in the urine. If these particles are present, that’s an indication there’s a kidney issue such as Chronic Kidney Disease (CKD). As of July 2022, over 100,000 Americans are using the test as part of a clinical evaluation, and Healthy.io has plans for a widespread commercial rollout to follow.
The test meets a significant need in America. According to the National Institutes of Health (NIH), around 37 million Americans (over 1 in 7 adults) are affected by CKD. And most of these millions of people are probably unaware of their health issues; the NIH estimates that as high as 9 in 10 people with CKD are unaware they have kidney disease. It’s understandable given that there are usually no symptoms associated with early stage kidney disease. When there are symptoms — including nausea, muscle cramps, and shortness of breath — the disease is often in an advanced stage and in danger of leading to kidney failure, heart attack, or stroke.
How does Minuteful work? In consultation with a healthcare provider, the user gets a test kit in the mail and downloads the Minuteful Kidney test app, which is available for both Android and iOS. The app’s chatbot nurse Emily offers a step-by-step guide through the test, which takes about 3 minutes ( which is why they call it “Minuteful”). The clinical-grade test examines the user’s urine sample on a test strip with help from an image of the strip taken with a smartphone, and the results are immediately shared with the user’s healthcare professional via the app.
Founded in 2013 by Israeli digital healthcare entrepreneur Yonatan Adiri, Healthy.io is building on the successes of its innovative digital solutions that include smartphone-powered wound management, detection of urinary tract infections, and prenatal care. Based in Tel Aviv, the healthcare company worked with U.S. health professionals for its latest initiative. Healthy.io’s Chief Product Officer Ron Zohar says, “The work conducted in collaboration with the leadership at the FDA’s Center for Devices and Radiological Health facilitated the development of AI innovation that will now deliver better digital health to the American public. We look forward to expanding our work with US payers and insurers in making sure every American with a smartphone can access this state-of-the-art technology.”