Nuwellis Installs Aquadex SmartFlow Devices at Pediatric Hospital, Upgrades Two Sites
NUWE•Nuwellis expands collaboration with a major South Carolina healthcare system to install Aquadex SmartFlow devices at one children’s hospital and upgrades two existing locations to the latest model. The company completed an FDA pre-submission meeting to extend its pediatric label to patients as small as 5 kg, targeting a submission by year-end 2026.
1. Expanded Pediatric Collaboration
Nuwellis has broadened its partnership with a leading South Carolina healthcare system to deploy Aquadex SmartFlow ultrafiltration devices at one of its children’s hospitals. This expansion marks the first introduction of the technology in that pediatric facility, enhancing clinical care programs for young patients with fluid overload.
2. Technology Upgrades at Existing Sites
The healthcare provider also upgraded to the latest Aquadex SmartFlow models at two locations that already used the system. These new devices offer improved control and predictability in fluid removal, supporting clinicians in managing pediatric cardiorenal conditions more effectively.
3. FDA Pre-Submission Meeting and Label Expansion
Nuwellis recently concluded a pre-submission meeting with the FDA to propose expanding its device label to include pediatric patients weighing down to 5 kg. The company plans to submit the formal request by the end of 2026, aiming to broaden its addressable market in the pediatric segment.
