Renalytix’s De Novo Authorization For KidneyIntelX.dkd Paves Way To Other Markets, Channels

Renalytix president Tom Mclain outlined the company’s commercial strategy for its AI-powered blood test to detect early-stage kidney disease in patients with diabetes.

DiabetesKidneydisease
• Source: Shutterstock

After a long wait, Renalytix AI plc  was finally granted de novo authorization from the US Food and Drug Administration for its AI-powered prognostic blood test, KidneyIntelX.dkd, which identifies early-stage kidney disease and guides the management of people with type 2 diabetes.

KidneyIntelX

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