FDA Approves PMA Supplement for Intercept Platelet System

December 08, 2025

The Food and Drug Administration’s Center for Biologics Evaluation and Research approved a 180-day premarket approval application supplement for the Cerus’s Intercept Blood System for platelets. The supplement authorizes updates to the package insert, including the addition of new 5-day in vivo recovery and survival data and revised hemovigilance information.