Fresenius advances U.S. launch of new dialysis machines

USA – Fresenius Medical Care is stepping up its U.S. launch of a new generation of dialysis machines following recent FDA clearance.

The company received updated 510(k) approval from the U.S. Food and Drug Administration in May 2025 for an enhanced version of its 5008X CAREsystem, a high-volume hemodiafiltration (HVHDF) machine designed to improve kidney replacement therapy.

This updated model features new enhancements, including the Fresenius Clinical Data Exchange (CDX) –a built-in tool that provides dialysis staff with one-touch access to a clinic’s medical information system directly from the treatment chair.

This technology aims to improve workflow, reduce clutter, and minimize infection risks by eliminating the need for separate computer stations and extra cabling.

The FDA had previously cleared the base version of the 5008X CAREsystem in February 2024, which Fresenius used for testing and user feedback in a pilot clinic.

The latest clearance now allows the company to begin broader deployment across its Fresenius Kidney Care clinics in the U.S., starting with select locations later this year. A full-scale commercial launch is planned for 2026.

The introduction of the 5008X CAREsystem marks a significant step forward for dialysis care in the U.S., where an estimated 160,000 in-center dialysis machines are currently in use across various providers.

Many of these could eventually be replaced as the 5008X system sets a new standard in care and operational efficiency.

Paired with its FDA-approved FX CorAL dialyzer, the 5008X CAREsystem represents one of Fresenius Medical Care’s most advanced innovations.

It blends modern device design with leading-edge membrane technology to make high-volume hemodiafiltration more accessible in everyday clinical settings.

This rollout comes as Fresenius continues to invest in improving patient care and clinic operations, offering more efficient, safer, and technologically advanced dialysis treatment options.