Fresenius Medical Care gains FDA 501(k) clearance for haemodialysis system

Betsy Goodfellow | February 9, 2024 | News story | Medical Communications 501(k), FDA, Fresenius Medical Care, Nephrology, dialysis 

Fresenius Medical Care has announced that it has received US Food and Drug Administration (FDA) 501(k) clearance for its 5008X Hemodialysis System. The company now intends to bring a new standard of care in dialysis treatment to patients with kidney diseases in the US.

This clearance follows results from the recently published CONVINCE study, which demonstrated that patients treated with high-volume haemodiafiltration experienced a 23% decrease in mortality rates compared to patients treated with the more commonly used high-flux haemodialysis.

Helen Giza, chief executive officer for Fresenius Medical Care, commented: “Making new and innovative therapies available to patients is core to our goal of improving the lives of people living with kidney diseases. The 5008X Hemodialysis System demonstrates our company’s ability to innovate at scale. This innovation builds on the proven track record of our haemodialysis system series in Europe, Latin America and Asia Pacific. We’re pleased to achieve this important milestone to bring a new standard of care in dialysis therapy to one of the world’s largest healthcare markets, where there is significant opportunity to make meaningful impact.”

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Betsy Goodfellow

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