Nuwellis installs Aquadex SmartFlow systems in Wisconsin

Nuwellis, Inc. (Nasdaq: NUWE) has installed its Aquadex SmartFlow® ultrafiltration systems at a pediatric healthcare institution in Wisconsin, marking the company's first entry into that state's pediatric market, according to a press release.

The installations are intended to support the development of clinical pathways and integrate Aquadex therapy into the hospital's pediatric care program. The institution was described only as a leading academic medical center in the region; Nuwellis did not identify it by name.

"Establishing our first pediatric program in Wisconsin reflects the continued momentum of our pediatric growth and increasing clinical adoption of our Aquadex therapy," said CEO Mike McCormick.

The Aquadex SmartFlow System is currently cleared for continuous ultrafiltration therapy in adult and pediatric patients weighing 20 kilograms or more whose fluid overload is unresponsive to medical management, including diuretics.

Nuwellis said it recently completed a pre-submission meeting with the U.S. Food and Drug Administration regarding a proposed label expansion to cover pediatric patients weighing 5 kilograms and above. The company said it anticipates submitting a 510(k) application to the FDA for the expanded label by the end of 2026.

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