Posted by Michael Wonder on 19 Oct 2023
FDA Grants SeaStar Medical’s selective cytopheretic device breakthrough device designation for hepatorenal syndrome
18 October 2023 - SeaStar Medical announces receipt of US FDA breakthrough device designation for its patented, first in class, cell-directed selective cytopheretic device for use with patients in the hospital intensive care unit with acute kidney injury and acute on chronic liver failure.
This is the third breakthrough device designation granted by the FDA to SeaStar Medical for the selective cytopheretic device device, and is expected to expedite the clinical development and regulatory review of the selective cytopheretic device for use in this patient population.
