FDA Grants Breakthrough Device Designation to SeaStar Medical's SCD Therapy for Hyperinflammation in Sepsis

SeaStar Medical Holding Corporation announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation for its Selective Cytopheretic Device (SCD) therapy. This designation is for treating hyperinflammation in adult patients with sepsis or a septic condition, aiming to accelerate the development and review process for this potentially life-saving treatment.