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KidneyIntelXs journey toward FDA recognition exemplifies the rigorous pathway required to translate an algorithmic risk score into a clinically deployed test, involving analytical validation, clinical validation, and demonstration of clinical utility ( 5.4 A transformative shift in disease management Beyond the specific predictive models validated in research settings, the application of AI and ML is catalyzing a transformative shift across the entire spectrum of DKD management (Figure 5)

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