Nuwellis, Inc. (Nasdaq: NUWE) has installed three Aquadex SmartFlow® systems at a pediatric healthcare provider in Michigan, marking the company's first pediatric program in the state, according to a press release.

The Aquadex SmartFlow system is designed to provide ultrafiltration therapy for adult and pediatric patients weighing 20 kilograms and above who have fluid overload and are unresponsive to medical management, including diuretics.

The installations are intended to support the development of clinical protocols and workflows to integrate Aquadex therapy into the hospital's pediatric care program.

"Adding our first pediatric program in Michigan advances our strategy to expand Aquadex adoption in pediatric care," said Nuwellis' incoming CEO Mike McCormick. "This collaboration provides an opportunity to establish protocols and clinical pathways that can support broader utilization of Aquadex therapy over time, creating a key entry into an as yet untapped market for Nuwellis."

Nuwellis also said it recently completed a pre-submission meeting with the U.S. Food and Drug Administration to discuss a proposed expansion of the Aquadex label to cover pediatric patients weighing 5 kilograms and above.