Renalytix Gets FDA De Novo Marketing Authorization for KidneyIntelX.dkd
June 29 2023 - 06:58PM
Dow Jones News
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)
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