Fresenius Medical Care Releases 5008X CAREsystem for High-Volume Hemodiafiltration

Fresenius Medical Care (FME) recently received U.S. Food and Drug Administration (FDA) 510(k) clearance for the updated version of its new, hemodiafiltration-capable 5008X CAREsystem.

The company said this starts the next phase of its efforts to introduce high-volume hemodiafiltration (HVHDF) kidney replacement therapy across the U.S.

The company first earned an FDA nod for the 5008X CAREsystem in February 2024, which let it conduct focused testing, clinical evaluations, and user studies in a pilot clinic. Last week’s 510(k) cleared additional features for the device, including Fresenius Clinical Data Exchange, a tech that enables ONE-TOUCH access to providers’ medical information systems (MIS) at the chairside, without further computer stations.

Direct access to providers’ MIS can help optimize clinic workflows, reduce cross-contamination risk and CMS V-tag citations, and reduce cabling and computer clutter.

FME’s Delivery patient care business will start offering hemodiafiltration dialysis therapy in a few months at first wave clinics in its U.S. dialysis clinics. The company said there’s an estimated installed base of about 160,000 in-center hemodialysis machines that could be replaced to adapt to this new standard of care.

The company’s CONVINCE study showed patients treated with high-volume hemodiafiltration had a 23% decrease in mortality rates compared to those treated with high-flux hemodialysis. The study compared the two types of hemodialysis techniques in a three-year trial at 61 European dialysis centers.

“Last week’s FDA clearance of our updated 5008X CAREsystem with additional features was a critical milestone in our work to improve the lives of people living with kidney disease by bringing industry-leading, high-volume hemodiafiltration dialysis therapy to the U.S.,” said Helen Giza, CEO for Fresenius Medical Care AG. “Hemodiafiltration is already the treatment standard across much of Europe, Latin America, and Asia, and we are very well experienced with it. Our great familiarity with this treatment, combined with the outcome and promising results of the external CONVINCE research study, reiterated the significant patient health and well-being benefits available with high-volume hemodiafiltration. With this additional clearance, we now begin the next steps of our national U.S. rollout by deploying the machine to a first wave of Fresenius Kidney Care clinics for the remainder of 2025 and continuing broadly across the U.S. in 2026 and beyond. It’s a landmark moment in the industry. We will set the new standard of kidney care in the U.S.”

Earlier this year, the company began an agreement to divest certain assets of its wholly-owned Spectra Laboratories business to Quest Diagnostics. Spectra Labs provides renal-specific lab testing services in the U.S.