Renalytix Gets FDA De Novo Marketing Authorization for KidneyIntelX.dkd
By Stephen Nakrosis
Renalytix said the Food and Drug Administration has granted De Novo marketing authorization for the KidneyIntelX.dkd prognostic test.
Renalytix said the authorization "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."
De Novo authorization provides a marketing pathway for novel medical devices, the FDA said.
Renalytix also said it believes the authorization will lead to increasing test adoption, expanding insurance coverage, and the pursuit of additional international regulatory approvals.
Write to Stephen Nakrosis at stephen.nakrosis@wsj.com
(END) Dow Jones Newswires
June 29, 2023 18:43 ET (22:43 GMT)
Copyright (c) 2023 Dow Jones & Company, Inc.-
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