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Nuwellis Announces Successful Completion of FDA Pre-Submission 510(k) Meeting to Expand Aquadex Label
Proposal would extend treatment access to pediatric patients weighing 5 kg and above MINNEAPOLIS, May 14, 2026 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq:
About this update from Nuwellis, Inc.
[{"type":"text","content":"Proposal would extend treatment access to pediatric patients weighing 5 kg and above\nMINNEAPOLIS, May 14, 2026 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE), a medical technology company committed to delivering solutions for patients with cardiorenal conditions, today announces the successful completion of a recent pre-submission meeting with the U.S. Food and Drug Administration (FDA) regarding the proposed label expansion of the Aquadex SmartFlow® System to support pediatric patients weighing 5 kg and above. The currently cleared indication is for patients weighing 20 kg and above. “In low-weight pediatric patients, fluid management is highly sensitive and requires careful clinical oversight,” said Nuwellis’ Director of Clinical Strategy Stuart Goldstein, M.D. “The ability to monitor hematocrit change in real-time provides an important additional layer of safety and insight that can support more informed ultrafiltration decisions. This type of capability becomes particularly valuable in smaller patients, where traditional approaches may be more limited.” Over the past 10 years, multiple publications from leading pediatric centers have demonstrated the safe and effective use of Aquadex in patients weighing less than the currently indicated 20 kg. The repeated utilization in the 5-20 kg population and evidence has demonstrated the need for expanding the labeling to reflect its consistent use for these patients. The pre-submission meeting provided constructive feedback on the Company’s proposed regulatory strategy, including a pathway toward a 510(k) submission supported by targeted bench testing, toxicological assessments, and pediatric clinical evidence. The feedback provides important clarity as Nuwellis advances its regulatory and clinical plans in this high-need patient population. The Company anticipates submitting to the FDA by the end of 2026. “Our work with leading pediatric centers has reinforced the importance of combining clinical experience with real-world evidence when evaluating therapies in this population. This includes extensive experience with both published and presented data validating the utility, and reinforcing the importance of expanding into this population,” said Nuwellis’ Senior Director of Medical Affairs Kelsey Newell. “This approach helps demonstrate how Aquadex can be used effectively within i...