Nuwellis' distribution partner, seastar medical, receives fda humanitarian device exemption for pediatric selective cytopheretic device quelimmune™

Minneapolis, feb. 22, 2024 (globe newswire) -- nuwellis, inc. (nasdaq: nuwe), a medical technology company focused on transforming the lives of people with fluid overload, today announced its distribution partner, seastar medical holding corporation (nasdaq: icu) (seastar medical), has received humanitarian device exemption (hde) from the u.s. food and drug administration (fda) for quelimmune™, its pediatric selective cytopheretic device. quelimmune provides a new therapy option for children weighing 10 kg or more who have acute kidney injury (aki) and sepsis or a septic condition requiring continuous kidney replacement therapy (ckrt) in a hospital intensive care unit.
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