Fresenius Medical Care Brings Industry-Leading Dialysis Therapy to Kidney Disease Patients in the U.S., demonstrating Global Leadership in Medical Device and Membrane Engineering Technologies
Fresenius Medical Care (FME) receives U.S. Food and Drug Administration (FDA) 510(k) clearance of the company's 5008X Hemodialysis System.
- Fresenius Medical Care (FME) receives U.S. Food and Drug Administration (FDA) 510(k) clearance of the company's 5008X Hemodialysis System.
- This will enable Fresenius Medical Care to offer the industry-leading, high-volume hemodiafiltration (Hv-HDF) dialysis therapy – already widely used in Europe – for people living with kidney diseases in the U.S.
- The 510(k) clearance allows the start of clinical evaluations and user-studies in the U.S., with a planned broad commercial launch of the 5008X Hemodialysis System in 2025.
- The 5008X Hemodialysis System and companion FX CorAL dialyzer demonstrate the company's global innovation leadership in medical device and membrane engineering technologies.