Hemanext One System Receives FDA Clearance for Expanded Use

March 11, 2026

Hemanext, an AABB corporate partner, announced that its Hemanext One System has received expanded 510(k) clearance from the Food and Drug Administration. The updated clearance allows blood establishments in the United States to use the system to process AS-3 leukocyte-reduced red blood cells (RBCs) derived from whole blood or apheresis collections.

Under the expanded indication, the Hemanext One System can process whole blood–derived or apheresis-derived CP2D/AS-3 leukocyte-reduced RBCs, as well as apheresis-derived ACD-A/AS-3 leukocyte-reduced RBCs.