Nuwellis clears FDA meeting to expand Aquadex use for pediatric patients from 20 kg to 5 kg.

Nuwellis successfully completed a pre-submission meeting with the FDA to expand the Aquadex SmartFlow System's label to include pediatric patients weighing as little as 5 kg, down from the current 20 kg. This expansion addresses a critical need for safer fluid management in low-weight children, supported by clinical evidence and real-world use. The company plans to submit the formal 510(k) application by the end of 2026, aiming to improve treatment options for pediatric patients requiring controlled ultrafiltration without full renal replacement therapy.