MINNEAPOLIS, Aug. 11, 2026 (GLOBE NEWSWIRE) -- Nuwellis, Inc. (Nasdaq: NUWE), a medical technology company committed to delivering solutions for patients with cardiorenal conditions, today announced a digital transformation program designed to position the Aquadex SmartFlow® System as a connected extracorporeal therapy platform for the modern intensive care environment. The program includes integration through Philips Capsule™ medical device interoperability technology and development of a next-generation tablet-based user interface. Together, these enhancements are expected to improve clinical workflow, strengthen interoperability with hospital information systems, and establish the digital foundation for future software-enabled innovations across the Aquadex platform.
The development program consists of two complementary initiatives. The first will integrate the Aquadex platform with leading electronic health record (EHR) systems, enabling therapy data generated during Aquadex treatments to be automatically transmitted into a patient's electronic medical record. The second initiative introduces a modern tablet-based user interface that will display key therapy information and device status in an intuitive, streamlined format designed to improve clinician workflow and ease of use. The digital architecture being developed is also expected to support future software-enabled decision support and advanced analytics capabilities as the platform evolves.
"As healthcare continues its digital transformation, clinicians increasingly expect medical devices to integrate seamlessly into the hospital ecosystem," said Mike McCormick, Nuwellis President and Chief Executive Officer. "We believe the future of extracorporeal therapy extends beyond fluid removal alone. It requires intelligent, connected platforms that integrate seamlessly into the ICU environment. These investments strengthen Aquadex today while creating the digital infrastructure that will support our next generation of products and capabilities."
This digital enhancement is one component of Nuwellis' broader innovation strategy to expand both the capabilities and clinical applications of the Aquadex platform. Together, these initiatives reflect the Company's commitment to continuously advance Aquadex through both hardware and software innovation. In addition to expanding therapeutic capabilities into adjacent extracorporeal applications, Nuwellis is investing in technologies that improve usability, connectivity, and integration within the increasingly digital intensive care environment.
Nuwellis expects to provide future updates regarding development milestones, regulatory activities, and commercialization plans as the program advances. The foregoing development initiatives are research-stage applications currently in development and are not yet approved, cleared, or licensed by the U.S. Food and Drug Administration (FDA). They are not currently available for commercial sale, distribution, or clinical use.
About Aquadex
The Aquadex SmartFlow System is currently indicated for the continuous ultrafiltration therapy for temporary (up to 8 hours) or extended (longer than 8 hours in patients who require hospitalization) use in adult and pediatric patients weighing 20 kilograms or more whose fluid overload is unresponsive to medical management, including diuretics. All treatments must be administered by a healthcare provider, within an outpatient or inpatient clinical setting, under physician prescription, both of whom having received training in extracorporeal therapies.
About Nuwellis
Nuwellis, Inc. (Nasdaq: NUWE) is a medical technology company committed to delivering solutions for patients with cardiorenal conditions. The Company develops solutions designed to support patient care through monitoring, therapy, and data-informed clinical decision-making across acute and chronic care settings. Nuwellis’ portfolio includes commercially available and development-stage technologies addressing complex cardiorenal conditions, with a focus on safety, precision, and scalability across patient populations. For more information, visit www.nuwellis.com.
Forward-Looking Statements
Certain statements in this release may be considered forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including without limitation, statements regarding the new market opportunities and anticipated growth in 2026 and beyond. Forward-looking statements are predictions, projections and other statements about future events that are based on current expectations and assumptions and, as a result, are subject to risks and uncertainties. Many factors could cause actual future events to differ materially from the forward-looking statements in this release, including, without limitation, those risks associated with our ability to execute on our commercialization strategy, the possibility that we may be unable to raise sufficient funds necessary for our anticipated operations, our post-market clinical data collection activities, benefits of our products to patients, our expectations with respect to product development and commercialization efforts, our ability to increase market and physician acceptance of our products, potentially competitive product offerings, intellectual property protection, our ability to integrate acquired businesses, our expectations regarding anticipated synergies with and benefits from acquired businesses, and other risks and uncertainties described in our filings with the SEC. Forward-looking statements speak only as of the date when made. Nuwellis does not assume any obligation to publicly update or revise any forward-looking statements, whether due to new information, future events or otherwise.
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