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

10/7/2026
Impact: 75
Healthcare

SeaStar Medical Holding Corporation (NASDAQ: ICU) has received FDA's Breakthrough Device Designation 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, marking the seventh such designation for the SCD therapy across various indications.

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