FDA grants breakthrough device designation to AI-enabled diagnostic for kidney disease

The FDA has granted breakthrough device designation to RenalytixAI’s artificial intelligence-enabled clinical diagnostic for kidney disease, known as KidneyIntelX, according to a press release from Mount Sinai, a collaborator on the project.

“We’re pleased RenalytixAI has received breakthrough designation for KidneyIntelX, providing the opportunity to work hand-in-hand with the FDA toward the goal of FDA submission,” Erik Lium, PhD, executive vice president of Mount Sinai Innovation Partners, said in the release. “Renal disease represents an increasing health care crisis globally, and early detection and intervention is essential in changing the course of this disease.”

KidneyIntelX, the first of its kind to receive this designation, is meant to both diagnose and improve clinical management of patients with type 2 diabetes and fast-progressing kidney disease, according to the release. Complete with machine learning algorithms, the diagnostic will be able to assess the combination of predictive blood-based biomarkers and use electronic health record information to determine if a patient has progressive kidney disease.

“This designation is a significant advancement toward our goal of bringing to market a solution that can greatly improve the identification and treatment of patients with chronic kidney disease,” Sally Bowden, chief operating officer of RenalytixAI, said in the release. “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.”

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