Fresenius Medical Care (FME) has begun the second phase of its efforts to introduce high-volume hemodiafiltration (HVHDF) kidney replacement therapy across the United States.
The company last week received FDA 510(k) clearance for the updated version of its new, hemodiafiltration-capable 5008X CAREsystem with additional features, a benchmark enabling the next steps in the company's broader commercialization efforts across the U.S. later this year, followed by a full-scale commercial launch in 2026.
Fresenius Medical Care first received 510(k) clearance for its 5008X CAREsystem in February 2024, which allowed the company to conduct focused testing, clinical evaluations, and user-studies of the device in a pilot clinic. Last week's May 2025 FDA 510(k) notice provided clearance for an updated 5008X CAREsystem with additional features, including the Fresenius Clinical Data Exchange (CDX), a unique Fresenius Medical Care technology built into the 5008X that enables ONE-TOUCH access to providers' medical information systems (MIS) directly at chairside without the need for additional computer stations. By providing direct access to providers' MIS, the CDX helps to optimize clinic workflows, reduce the risk of cross contamination and CMS V-tag citations, and open up clinic space by reducing computer and cabling clutter.
Beginning in a few months and continuing through the remainder of the year, Fresenius Medical Care's Care Delivery patient care business segment will begin offering hemodiafiltration dialysis therapy in selected first wave clinics across regions in its U.S. Fresenius Kidney Care dialysis clinics. In the U.S. there is an estimated installed base of around 160,000 in-center hemodialysis machines across all service providers that could be replaced to adapt this new standard of care.
The 5008X CAREsystem is one of Fresenius Medical Care's latest medical device innovations. Along with the companion FX CorAL dialyzer – approved by FDA –, the 5008X CAREsystem combines the latest device engineering and cutting-edge membrane technologies that facilitate high-volume hemodiafiltration with many additional workflow and therapy improvements possible.
