Nuwellis completes Aquadex SmartFlow System pre-submission meeting with the FDA

Nuwellis (NUWE) announced the completion of a recent pre-submission meeting with the 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. The company said, “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.”