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NEW YORK – RenalytixAI on Thursday announced the submission of a 510(k) application to the US Food and Drug Administration for its KidneyIntelX assay.  

The London-based firm is seeking FDA clearance for use of KidneyIntelX, in combination with clinical evaluation, as an aid to further determine the risk of progressive decline in kidney function for up to five years in patients over the age of 21 with type 2 diabetes and chronic kidney disease (CKD).

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