RenalytixAI Hits Milestone with Break Through Designation

RenalytixAI has won  Break Through Device designation from FDA for KidneyIntelX a technology that could help diagnose kidney disease. This is the first such designation for an AI-enabled diagnostic for kidney disease publicly announced by any company.
KidneyIntelx was designed in an effort to curtail the estimated $114 billion annual cost of chronic and end-stage kidney disease to the U.S. healthcare system.
“The technology is a combination of a multiplex lab-based test measuring three biomarkers (sTNFR1, sTNFR2 and KIM1) that are shown to be prognostic in nature for rapid progression of kidney disease,” Sally Bowden, COO, RenalytixAI, told MD+DI. “This is combined with historical and longitudinal data from the patient’s electronic health records. Using machine learning to derive algorithms combined with biomarker data has shown to be predictive of a patient that has type 2 diabetes to progress to chronic kidney disease.”
Bowden noted that it was an honor to receive Breakthrough Designation from FDA and that the guidance can be beneficial.
“Breakthrough Designation means [FDA] is available through a variety of different channels to review our data development plan; to review our validation protocol; and really provide feedback throughout the design control and clinical validation process," she said. "The importance of having that feedback and hav...

Source: MDDI - May 3, 2019 Category: Medical Devices Authors: Omar Ford Tags: Digital Health Source Type: news