Posted by Michael Wonder on 04 May 2022
SeaStar Medical granted FDA breakthrough device designation for a novel immunomodulatory therapy for acute kidney injury patients
3 May 2022 - Designation helps enable accelerated regulatory review of up-coming pivotal clinical trial for treatment in adult patients with acute kidney injury.
SeaStar Medical today announced that SeaStar Medical’s selective cytopheretic device has received a breakthrough device designation from the U.S. FDA.
