India, Nov. 5 -- Nuwellis, Inc. (NUWE), a medical technology company focused on cardiorenal conditions, announced that it has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) seeking to expand the indication for its Aquadex SmartFlow System to include pediatric patients weighing 5 kg and above. The system is currently cleared for patients weighing 20 kg and above.
The submission follows a pre-submission meeting with the FDA in April 2026 and is supported by peer-reviewed clinical evidence, performance verification data, pediatric-specific safety analyses and updated toxicological assessments.
The regulatory filing includes findings from the ULTRA-Peds Registry, which was accepted for publication in ...