Renalytix has received FDA authorisation for their KidneyIntelX.dkd kidney prognostic test which will open the doors to further clinical testing and insurance coverage.
The device utilises AI to provide care management for people with kidney disease brought on by diabetes.
“Meeting the rigorous safety, clinical and analytical validation, and scientific data requirements of an FDA review, from Breakthrough Device designation to De Novo marketing authorization, is a landmark event for health care providers and patients with diabetic kidney disease,” said James McCullough, CEO of Renalytix.
“With this approval, a new class, Prognostic Test for Assessment of Chronic Kidney Disease Progression, has been established by the FDA, providing a roadmap for future expansion of KidneyIntelX into new indications and products.”