Nuwellis Submits 510(k) Premarket Notification To FDA Seeking To Expand Indication Of Aquadex SmartFlow System To Include Pediatric Patients Weighing 5 Kg And Above

Nuwellis, Inc. (NASDAQ:NUWE), a medical technology company committed to delivering solutions for patients with cardiorenal conditions, today announced that it has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) seeking to expand the indication of its Aquadex SmartFlow® System to include pediatric patients weighing 5 kg and above. The system is currently cleared for use in patients weighing 20 kg and above.

The submission follows the Company's pre-submission meeting with FDA in April 2026 and builds on a growing body of peer-reviewed pediatric clinical evidence. Most recently, on October 27, Nuwellis announced the acceptance of the multicenter ULTRA-Peds Registry in Pediatric Nephrology, evaluating 91 pediatric patients across seven children's hospitals, including 67 patients weighing less than 20 kg. This important scientific publication, together with previously published pediatric research, informed the Company's regulatory strategy and contributed to the clinical evidence supporting its proposed label expansion. The 510(k) submission also includes existing performance verification data, pediatric-specific safety analyses, and updated toxicological assessments supporting the proposed expanded indication.