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Medical Devices / Submissions and Approvals

Healthy.io Gets FDA Clearance for Kidney Disease Diagnostic

Sept. 17, 2019

Israeli medical device developer Healthy.io has earned the FDA’s 510(k) clearance for its smartphone-based diagnostic test for chronic kidney disease.

The clearance allows the company to expand access to “millions of Americans suffering from diabetes and hypertension, who are at risk for chronic kidney disease,” said Yonatan Adiri, founder and CEO of Healthy.io.

The clearance means the urine test may now be used at any point of care by healthcare professionals. It has the same capabilities  as lab-based testing, the company said.

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