Benzinga | Aug 31, 2020 07:31AM EDT

Baxter Announces FDA De Novo Authorization for Theranova Dialyzers Enabling HDx Therapy

* U.S. patients with kidney failure now have access to expanded hemodialysis (HDx) therapy delivered by Theranova, a new class of dialyzer

* Theranova dialyzer's unique membrane design offers a filtration profile that more closely mimics that of the natural kidney and can be used with existing hemodialysis machines1,2

* Theranova was reviewed by FDA through the De Novo process, a pathway for novel low- to moderate-risk devices