Breakthrough device designation to kidney diagnosticJuly 4, 2019
The US FDA has granted Breakthrough Device designation to renal disease diagnostic, KidneyIntelX. KidneyIntelX is designed to diagnose patients with type II diabetes with fast-progressing kidney disease.
The diagnostic will use machine learning algorithms to assess the combination of predictive blood-based biomarkers, including sTNFR1, sTNFR2, and KIM1, in combination with electronic health record information, to identify progressive kidney disease, Renalytix AI plc said.
KidneyIntelX is being developed in collaboration with the Mount Sinai Health System.
The FDA’s Breakthrough Devices Program is a voluntary programme for certain medical devices and device-led combination products that provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.