LAS VEGAS (KTNV) — Nevada has some of the highest rates of kidney disease in the nation but now, a new device that was just cleared by the Food and Drug Administration could change that statistic.
Healthy.io, the company that transformed the smartphone camera into a medical device, announced that it received 510(k) clearance from the U.S. Food and Drug Administration for home use of the Minuteful Kidney test.
The test is the first of its kind to receive FDA clearance across all IOS and Android devices. This clearance allows people to use their smartphone camera to conduct a urine test that identifies a specific protein in the urine called albumin, which is the standard of care for detecting early signs of CKD.
Currently, an Albumin-to-creatinine ratio test is recommended for people at risk of developing chronic kidney disease. Until now, the test could only be done by a medical practitioner.
As a result, 60 million Americans - roughly 80% of at-risk patients - fail to complete their annual test.
CKD is often referred to as the silent killer because it doesn’t show symptoms until the very late stages where treatment would require dialysis and/or a kidney transplant.
“Really, if you have a smartphone and if you can text or take a picture, you now can get really good checks on your health. 75 million Americans are at risk. That's a really big number. One in seven people have kidney disease and don’t know it,” said Paula LeClair, the U.S. general manager with Healthy.io.
"In effect, Minuteful Kidney™ is a digital antidote that can help every person at-risk dramatically decrease their probability of undergoing dialysis. We look forward to bringing our technology to millions of Americans across all socioeconomic levels, preventing CKD, lowering rates of dialysis, and reducing healthcare costs," said Healthy.io founder and CEO Yonatan Adiri.