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Nuwellis Announces Acceptance of Multicenter Pediatric Aquadex Study in Pediatric Nephrology
Nuwellis announced publication of the ULTRA-Peds Registry study in Pediatric Nephrology, evaluating 91 pediatric patients across seven children's hospitals using the Aquadex SmartFlow System. The study demonstrated 87% patient survival rates and 86.5% procedure completion without interruption, with 62% of patients weighing less than 10 kg. These findings support the company's proposed FDA label expansion for Aquadex from patients weighing 20 kg and above to those weighing 5 kg and above, following a successful pre-submission meeting with the FDA earlier in 2026.