SeaStar Medical Receives FDA's Medical Breakthrough Device Designation For Its Selective Cytopheretic Device Therapy To Treat Hyperinflammation

SeaStar Medical Holding Corporation (NASDAQ: ICU) has received Breakthrough Device Designation from the FDA for its Selective Cytopheretic Device (SCD) therapy, aimed at treating hyperinflammation in adult patients with sepsis. This designation facilitates accelerated development and review for FDA approval of the device, which is intended for life-threatening conditions. This is the seventh Breakthrough Device Designation granted for the SCD therapy across various indications.