Shots:

• The US FDA has granted De Novo authorization to Theranova that delivers expanded hemodialysis (HDx) therapy by filtering the wider range of molecules from the blood- targeting the effective removal of conventional (500-25 kDa) and large middle molecules (25-45 kDa)
• The Theranova cartridge is designed to be used with existing dialysis machines and offers a filtration profile that more closely mimics the natural kidney
• The FDA utilizes the De Novo pathway for low and moderate risk medical devices with no existing predicate in the US. Theranova is currently available in 44 countries across EU- Latin America- Asia- and in Canada- and used in 850+ clinics globally

­ Ref: Baxter | Image: Medical Expo