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FDA grants Breakthrough Device designation
FDA grants Breakthrough Device designation.
About this update from Renalytix Plc
[{"type":"text","content":"\n \nRNS Number : 8260X Renalytix AI PLC 02 May 2019 \n\n \nTHE INFORMATION CONTAINED IN THIS ANNOUNCEMENT IS DEEMED BY THE COMPANY TO CONSTITUTE INSIDE INFORMATION AS STIPULATED UNDER ARTICLE 7 OF REGULATION (EU) NO 596/2014. UPON PUBLICATION OF THIS ANNOUNCEMENT VIA A REGULATORY INFORMATION SERVICE, THIS INFORMATION IS CONSIDERED TO BE IN THE PUBLIC DOMAIN.\n \nRenalytix AI plc\n(\"RenalytixAI\" or the \"Company\")\n \nFDA grants Breakthrough Device designation to KidneyIntelX™\n \nProvides priority regulatory review of AI-enabled diagnostic for fast-progressing kidney disease\n \nRenalytix AI plc (AIM: RENX), a developer of artificial intelligence-enabled clinical diagnostics for kidney disease, announces that it has been granted Breakthrough Device designation by the U.S. Food and Drug Administration (FDA), for its lead diagnostic, KidneyIntelX™. This is the first such designation for an AI-enabled diagnostic for kidney disease publicly announced by any company.\n \nKidneyIntelXTM is designed to diagnose and improve clinical management of patients with Type II diabetes with fast-progressing kidney disease, in an effort to curtail the estimated $114 billion annual cost1 of chronic and end-stage kidney disease to the United States healthcare system. 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. KidneyIntelXTM is being developed in close collaboration with the Mount Sinai Health System.\n \nThe 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. The goal of the programme is to provide patients and health care providers with timely access to these medical devices by speeding up their development, assessment and review, while preserving the statutory standards for premarket approval, 510(k) clearance and De Novo marketing authorisation, consistent with the Agency's mission to protect and promote public health.\n \nSally Bowden, Chief Operating Officer of RenalytixAI, said: ...