AI-powered kidney disease and transplant management diagnostic developer RenalytixAI said yesterday that it received an FDA breakthrough device designation for its KidneyIntelX artificial-intelligence powered diagnostic for kidney disease.
The New York-based company touted the FDA clearance as the first ever for an AI-powered kidney disease diagnostic.
The KidneyIntelX is designed to diagnose and improve clinical management of patients for patients with Type II diabetes and fast-progressing kidney disease, RenalytixAI said. The diagnostic uses machine learning algorithms to assess the combination of blood-based biomarkers and EHR info to identify progressive kidney disease.
“This designation is a significant advancement towards our goal of bringing to market a solution that can greatly improve the identification and treatment of patients with chronic kidney disease. We look forward to continuing to work closely with the FDA through this process, including on our data development plan, our clinical validation and our subsequent submission for regulatory clearance,” COO Sally Bowden said in a prepared statement.
The company said that the KidneyIntelX is being developed in close collaboration with 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,” Mount Sinai Innovation Partners exec VP Erik Lium, said in a press release.
Last November, RenalytixAI said that it completed an $29 million initial public offering on the London Stock Exchange’s Alternative Investment Market.