"Provides Priority Regulatory Review of AI-Enabled Diagnostic for Fast-Progressing Kidney Disease"
Renalytix AI plc (RENX.L), 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, for its lead diagnostic, KidneyIntelX.™ The diagnostic will use machine learning algorithms to assess the combination of predictive blood-based biomarkers, in combination with electronic health record information, to identify progressive kidney disease. KidneyIntelX™ is being developed in close collaboration with the Mount Sinai Health System. "We're pleased RenalytixAI has received Breakthrough Designation for KidneyIntelX, providing the opportunity to work hand-in-hand with the FDA towards the goal of FDA submission. Renal disease represents an increasing healthcare crisis globally, and early detection and intervention is essential in changing the course of this disease," said Erik Lium, PhD, and executive vice president of Mount Sinai Innovation Partners.
— Erik Lium, PhD, Executive Vice President, Mount Sinai Innovation Partners