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

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

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

Click here ­to­ read full press release/ article | Ref: Baxter | Image: Medical Expo

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

Related post