Nuwellis announces EHR connectivity program for Aquadex platform

Nuwellis, Inc. (Nasdaq: NUWE) announced a digital development program for its Aquadex SmartFlow System, including electronic health record integration and a new tablet-based user interface, according to a company statement.

The program has two components. The first involves integrating the Aquadex platform with EHR systems using Philips Capsule medical device interoperability technology, which would allow therapy data from Aquadex treatments to be automatically transmitted into patient medical records. The second introduces a tablet-based interface designed to display therapy information and device status in a streamlined format.

The company said the digital architecture is also intended to support future software-enabled decision support and analytics capabilities. Nuwellis said it expects to provide updates on development milestones, regulatory activities, and commercialization plans as the program advances.

The initiatives are currently research-stage applications and have not been approved, cleared, or licensed by the U.S. Food and Drug Administration. They are not available for commercial sale, distribution, or clinical use.

"We believe the future of extracorporeal therapy extends beyond fluid removal alone," said Mike McCormick, Nuwellis President and Chief Executive Officer. "It requires intelligent, connected platforms that integrate seamlessly into the ICU environment."

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.

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