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Medical Devices / Submissions and Approvals

FDA Issues Breakthrough Designation for Kidney Disease Test

May 8, 2019
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Clinical test developer Renalytix received a breakthrough device designation from the FDA for its lead diagnostic KidneyIntelX.

The AI-enabled kidney disease diagnostic, the first of its kind, identifies patients with Type II diabetes with fast-progressing kidney disease.

The diagnostic uses machine-learning algorithms to evaluate predictive blood-based biomarkers, as well as a patient’s electronic health records, to detect progressive kidney disease.

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