Fresenius Medical Care Receives FDA Clearance for Updated 5008X CAREsystem, Expanding High-Volume Hemodiafiltration in U.S.

Fresenius Medical Care Receives FDA Clearance for Updated 5008X CAREsystem, Expanding High-Volume Hemodiafiltration in U.S.

(IN BRIEF) Fresenius Medical Care has received FDA 510(k) clearance for its updated 5008X CAREsystem with additional features, enabling the introduction of high-volume hemodiafiltration therapy across the U.S. This new therapy, proven to reduce mortality rates by 23% in patients, will be rolled out in selected Fresenius Kidney Care clinics starting in 2025, with a full-scale commercial launch planned for 2026. The 5008X CAREsystem integrates innovative features like the Fresenius Clinical Data Exchange® (CDX) to optimize clinic workflows and improve patient care.

(PRESS RELEASE) BAD HOMBURG, 5-Jun-2025 — /EuropaWire/ — Fresenius Medical Care (FME), the global leader in products and services for individuals with renal diseases, has received FDA 510(k) clearance for the updated 5008X CAREsystem with additional features. This marks a key milestone in the company’s ongoing efforts to introduce high-volume hemodiafiltration (HVHDF) kidney replacement therapy in the United States, with the first wave of Fresenius Kidney Care clinics set to begin offering this therapy in 2025, followed by a full commercial launch in 2026.

“The FDA clearance for the updated 5008X CAREsystem is a critical step in our mission to bring high-volume hemodiafiltration to the U.S.,” said Helen Giza, CEO of Fresenius Medical Care AG. “Hemodiafiltration is already the treatment standard in many parts of Europe, Latin America, and Asia. Our extensive experience with this therapy, combined with the promising outcomes from the CONVINCE* study, reinforces the significant health benefits it offers to kidney patients. This clearance sets the stage for the next phase of our U.S. rollout, as we introduce the technology in Fresenius Kidney Care clinics across the country.”

Fresenius Medical Care initially received FDA 510(k) clearance for the 5008X CAREsystem in February 2024, allowing for pilot testing and clinical evaluations in selected clinics. The recent clearance includes new features, notably the Fresenius Clinical Data Exchange® (CDX), a groundbreaking technology integrated into the 5008X that provides ONE-TOUCH access to patient data from medical information systems (MIS) directly at the chairside. This integration optimizes clinic workflows, reduces cross-contamination risks, and minimizes clutter from computer stations and cables, contributing to enhanced clinic efficiency.

As part of its broader commercialization efforts, Fresenius Medical Care will introduce hemodiafiltration therapy in a select group of Fresenius Kidney Care dialysis clinics in the U.S. throughout 2025. The company estimates that about 160,000 in-center hemodialysis machines in the U.S. could eventually be replaced with this new standard of care.

The 5008X CAREsystem, paired with the FDA-approved FX CorAL® dialyzer, combines cutting-edge engineering and advanced membrane technologies that facilitate high-volume hemodiafiltration, offering improved outcomes and efficiency. This system is part of Fresenius Medical Care’s strategy to expand access to innovative kidney care solutions.

The results of the CONVINCE* study, a multinational research initiative funded by the European Union, demonstrated a 23% reduction in mortality rates for patients treated with high-volume hemodiafiltration compared to those receiving high-flux hemodialysis. Conducted across 61 dialysis centers in eight European countries, the CONVINCE study has significantly reinforced the clinical benefits of high-volume hemodiafiltration as a superior treatment option.

About Fresenius Medical Care:
Fresenius Medical Care is the world’s leading provider of products and services for individuals with renal diseases, serving around 4.2 million patients worldwide. The company operates 3,674 dialysis clinics globally, providing treatment for approximately 299,000 patients. Fresenius Medical Care is also a leading manufacturer of dialysis products, such as dialysis machines and dialyzers. The company is listed on the Frankfurt Stock Exchange (FME) and the New York Stock Exchange (FMS).

*The CONVINCE study, funded by the European Union and led by the University Medical Center Utrecht, is a randomized controlled trial that compared high-volume hemodiafiltration with standard high-flux hemodialysis.

About Fresenius Medical Care:
Fresenius Medical Care is the world’s leading provider of products and services for individuals with renal diseases of which around 4.2 million patients worldwide regularly undergo dialysis treatment. Through its network of 3,674 dialysis clinics, Fresenius Medical Care provides dialysis treatments for approx. 299,000 patients around the globe. Fresenius Medical Care is also the leading provider of dialysis products such as dialysis machines or dialyzers. Fresenius Medical Care is listed on the Frankfurt Stock Exchange (FME) and on the New York Stock Exchange (FMS).

*Funded by the European Union, conducted by the CONVINCE consortium, and led by the University Medical Center Utrecht, the international, randomized controlled CONVINCE trial marked a crucial milestone in comparing high-volume hemodiafiltration with standard, high-flux hemodialysis.

The information in this document is provided as is and no guarantee or warranty is given that the information is fit for any particular purpose. The user thereof uses the information at its sole risk and liability. The opinions expressed in the document are of the authors only and in no way reflect the European Commission’s opinions.

The CONVINCE study was exclusively supported by the European Commission Research & Innovation, Horizon 2020, Call H2020-SC1-2016-2017 under the topic SC1-PM-10-2017: Comparing the effectiveness of existing healthcare interventions in the adult population (grant no 754803).

Disclaimer:
This release contains forward-looking statements that are subject to various risks and uncertainties. Actual results could differ materially from those described in these forward-looking statements due to various factors, including, but not limited to, changes in business, economic and competitive conditions, legal changes, regulatory approvals, results of clinical studies, foreign exchange rate fluctuations, uncertainties in litigation or investigative proceedings, and the availability of financing. These and other risks and uncertainties are detailed in Fresenius Medical Care’s reports filed with the U.S. Securities and Exchange Commission. Fresenius Medical Care does not undertake any responsibility to update the forward-looking statements in this release.

Media Contacts:

Christine Peters
Tel: +49 160 60 66 770
email: christine.peters@freseniusmedicalcare.com

Emanuela Cariolagian
Tel: +1 213 706 0051
email: emanuela.cariolagian1@freseniusmedicalcare.com

analysts and investors

Dr. Dominik Heger
Tel: +49 6172 609 2601
email: dominik.heger@freseniusmedicalcare.com

www.freseniusmedicalcare.com

SOURCE: Fresenius SE & Co. KGaA