SeaStar Medical's Sepsis Therapy Receives FDA Breakthrough Status

The FDA has granted Breakthrough Device Designation to SeaStar Medical's Selective Cytopheretic Device (SCD) for treating hyperinflammation in adult sepsis patients. This designation aims to expedite the development and review of the therapy, addressing a critical need as there are currently no FDA-approved treatments for dysregulated inflammatory response in sepsis. This could accelerate a new treatment option for a severe condition.