AI diagnostic gets FDA Breakthrough Device designation
A Mount Sinai Health System startup, seeking to commercialize an artificial intelligence-enabled clinical diagnostic for kidney disease, has been granted priority regulatory review by the Food and Drug Administration.
The FDA has designated RenalytixAI’s KidneyIntelX as a Breakthrough Device, effectively fast-tracking its development, assessment and review.
The agency’s Breakthrough Devices Program—a voluntary program first authorized in late 2016—is intended to preserve the statutory standards for premarket approval, 510(k) clearance and De Novo marketing authorization, while providing timely access to new solutions for treating or diagnosing a disease or condition that have significant advantages over existing treatment or diagnostic alternatives.
“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,” said Sally Bowden, chief operating officer of RenalytixAI. “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.”
KidneyIntelX, which is designed to diagnose and improve clinical management of patients with Type II diabetes, leverages machine learning algorithms to assess the combination of predictive blood-based biomarkers—along with electronic health record information—to identify progressive kidney disease.
According to Mount Sinai, which is developing KidneyIntelX in close collaboration with RenalytixAI, this is the FDA’s first Breakthrough Device designation for an AI-enabled diagnostic for kidney disease that has been publicly announced by any vendor.
“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,” said Erik Lium, executive vice president of Mount Sinai Innovation Partners. “Renal disease represents an increasing healthcare crisis globally, and early detection and intervention is essential in changing the course of this disease.”