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FDA Grants Breakthrough Device Designation to KidneyIntelX, AI-Enabled Diagnostic for Kidney Disease

15:13 EDT 2 May 2019 | Speciality Pharma Journal

NEW YORK, May 2, 2019 /PRNewswire/ — Renalytix AI plc (LON: RENX), a developer of artificial intelligence-enabled clinical diagnostics for kidney disease, announced today that it has been granted Breakthrough Device designation by the U.S. Food and Drug Administration (FDA), for its lead diagnostic, KidneyIntelX™. This is the first such designation for an AI-enabled diagnostic …

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