Nuwellis Installs Three Aquadex Systems in Michigan Pediatric Hospital, Pursues FDA Label Expansion
NUWE•Nuwellis installed three Aquadex SmartFlow systems at a leading Michigan pediatric hospital, marking its first pediatric program in the state and establishing a base for future consumable sales. The company also completed an FDA pre-submission meeting to extend Aquadex labeling down to 5-kilogram patients, targeting broader pediatric adoption.
1. Pediatric Installations in Michigan
Nuwellis placed three Aquadex SmartFlow systems at a leading pediatric hospital in Michigan, marking its first pediatric program in the state. The installations support precise ultrafiltration therapy for patients weighing 20 kilograms and above who are unresponsive to diuretics.
2. Clinical Protocols and Consumable Growth
The company will collaborate with clinicians to develop clinical protocols and workflows, aiming to integrate Aquadex therapy into routine pediatric care. This foundation is intended to drive future consumable utilization and long-term revenue growth in the pediatric critical care segment.
3. FDA Label Expansion Prospects
Nuwellis recently held a pre-submission meeting with the FDA to discuss expanding Aquadex labeling to include patients weighing 5 kilograms and above. Approval of the expanded label could open access to lower-weight pediatric patients and accelerate adoption across additional pediatric centers.
