FDAnews Device Daily Bulletin
Medical Devices / Submissions and Approvals

FDA Issues Breakthrough Designation for Kidney Disease Test

May 8, 2019

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.

View today's stories