FDA Confirms SeaStar Medical Fulfilled Post-Approval Study Requirements for QUELIMMUNE® in Pediatric Sepsis-Associated AKI

SeaStar Medical Holding Corporation announced that the FDA's Center for Biologics Evaluation and Research (CBER) has determined that the QUELIMMUNE Pediatric SAVE Surveillance Registry has fulfilled the post-approval study requirements for QUELIMMUNE. This device is approved for treating life-threatening Acute Kidney Injury (AKI) due to sepsis in critically ill pediatric patients requiring renal replacement therapy.