Fresenius Medical Care announced the beginning of broader U.S. commercialization for its 5008X™ CAREsystem, which enables High-Volume Hemodiafiltration (HVHDF) kidney replacement therapy. This follows the FDA's 510(k) clearance in May 2025 for an updated version of the system with additional features, including the Fresenius Clinical Data Exchange® (CDX).
The initial 510(k) clearance for the 5008X CAREsystem was received in February 2024, allowing for pilot testing. The updated clearance paves the way for a phased U.S. launch starting in Q3 2025, with a full commercial rollout planned for 2026. The company aims to replace all existing 2008T machines in its U.S. clinics with the 5008X by 2030.
HVHDF therapy has demonstrated significant patient benefits, with the European CONVINCE study showing a 23% decrease in mortality rates compared to standard high-flux hemodialysis. This advanced therapy is expected to set a new standard of care in the U.S., improving patient outcomes and offering operational efficiencies for clinics.
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