Nuwellis provides regulatory update on seastar medical's selective cytopheretic device use in pediatric acute kidney injury under a humanitarian device exemption

Minneapolis, oct. 10, 2023 (globe newswire) -- nuwellis, inc. (nasdaq: nuwe) (nuwellis), a medical technology company dedicated to transforming the lives of people with fluid overload, today announced that its distribution partner, seastar medical (seastar), received correspondence from the u.s. food and drug administration's (fda) center for biologics evaluation and research (cber) indicating that the agency considers seastar's selective cytopheretic device (scd) pediatric (scd-ped) to be approvable under a humanitarian device exemption (hde) for use in children weighing 10 kilograms or more with acute kidney injury (aki) and sepsis or a septic condition requiring continuous kidney replacement therapy (ckrt) in the hospital intensive care unit (icu).
NUWE Ratings Summary
NUWE Quant Ranking