StocksMedium•7 October 2026•
1 min read
SeaStar Medical Gets FDA Breakthrough Status for Sepsis Therapy
Key Facts
1The U.S. FDA has granted SeaStar Medical Breakthrough Device Designation for its SCD therapy to treat hyperinflammation in adult sepsis patients.
The U.S. FDA has granted SeaStar Medical Breakthrough Device Designation for its SCD therapy to treat hyperinflammation in adult sepsis patients. GlobeNewswire reported that the designation is intended to accelerate the development and regulatory review process for the Selective Cytopheretic Device (SCD) therapy.
ICU closed at $3.19 on October 6, 2026, with the stock reaching a session high of $3.5 and a low of $3.07. The regulatory milestone addresses a critical healthcare need, as sepsis affects approximately 1.7 million U.S. adults annually and remains a leading cause of hospital mortality.