FDA grants De Novo Marketing Authorization for KidneyIntelX.dkd to assess risk of progressive kidney function decline in adults with diabetes and early-stage kidney disease – Renalytix plc

Renalytix plc announces that the FDA has granted De Novo marketing authorization for its KidneyIntelX.dkd prognostic test. This affirms KidneyIntelX as a first-in-class, artificial intelligence enabled prognostic testing platform to guide care management for adults with type 2 diabetes and early-stage chronic (diabetic) kidney disease. Renalytix believes FDA authorization will lead to increasing test adoption, informing clinical guidelines, expanding insurance […]