SeaStar Medical Receives FDA Breakthrough Device Designation for Novel Therapy
SeaStar Medical has been granted a Breakthrough Device Designation by the FDA for its Selective Cytopheretic Device (SCD), aimed at treating acute kidney injury (AKI) in adults. This designation facilitates an expedited regulatory review for the upcoming pivotal clinical trial of the SCD, which targets hyperinflammation by selectively addressing activated neutrophils and monocytes.