Hemanext Receives FDA Marketing Authorization for RBC Processing and Storage System

The Food and Drug Administration has granted marketing authorization for commercial distribution via the De Novo process to Hemanext for the company’s Hemanext One blood processing and storage system. Hemanext One is the only FDA-authorized RBC processing and storage system designed to limit oxygen in the storage environment.

The Hemanext One RBC processing and storage system limits oxygen, the fuel for oxidative damage, which has the potential to benefit patients requiring transfusion for chronic conditions such as thalassemia, sickle cell disease (SCD), and myelodysplastic syndromes (MDS). The new system may also benefit those in need of critical transfusions during post-traumatic surgery and other medical procedures.