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Minuteful Kidney Receives FDA Clearance

We are excited to share some big news for Healthy.io. Today we’re announcing that we’ve received 510(k) clearance from the U.S. Food and Drug Administration for our Minuteful Kidney test, allowing people to test their kidney function from home and get clinical-grade results instantly. 

Our solution is the first smartphone-powered home kidney test to receive FDA clearance and the first test to receive FDA clearance across all current iOS and Android devices. It’s also a further testament to the solution’s ability to deliver clinical-grade results at scale.

An annual urine albumin-to-creatinine test is the gold standard for detecting kidney disease early, but roughly 80% of at-risk people don’t complete the test. That’s 60 million untested Americans at a high risk of kidney failure, as well as associated health issues like heart attack and stroke. Testing rates are even lower among underserved communities, further contributing to health disparities.  

Minuteful Kidney shifts testing from the lab to the home. By removing the challenges and barriers associated with traditional lab testing and other home testing solutions, it dramatically increases testing adherence. With this new clearance, plans will be able to screen patients at scale, detect undetected cases and treat them, helping reduce the annual $120 billion cost of kidney disease.

"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. Healthy.io has provided an easy way to provide patients and clinicians with potentially life-saving information."

George Bakris, M.D., Director of the Comprehensive Hypertension Center, University of Chicago and the American Diabetes Association

We’ve already seen the impact that Minuteful Kidney can have. In clinical evaluations covering more than 100,000 members, conducted in partnership with leading US insurers, we’ve successfully raised testing adherence up to 50% among previously untested populations irrespective of demographic and socio-economic differences.

In the United Kingdom, Minuteful Kidney was adopted by the National Health Service as the leading AI tool enabling early warning of kidney disease. We’re proud to be engaging with 540,000 people in the UK, who are at risk of chronic kidney disease, and to be improving care and patient outcomes as well as driving £615m potential savings for the NHS.

This is a milestone to celebrate—because of all the hard work that led to it, the opportunity we now have to help improve the lives of millions of people in the United States, and because of the many milestones yet to come.

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