Logo

Baxter's Theranova Dialyzers Receives the US FDA's De Novo Authorization to Deliver HDx Therapy

Share this

Baxter's Theranova Dialyzers Receives the US FDA's De Novo Authorization to Deliver HDx Therapy

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

Click here to­ read the full press release 

Senior Editor

This content piece was prepared by our former Senior Editor. She had expertise in life science research and was an avid reader. For any query reach out to us at connect@pharmashots.com

Share this article on WhatsApp, LinkedIn and Twitter

Join the PharmaShots family of 12000+ subscribers

I accept the Terms and Conditions