Fresenius Medical Care Receives FDA Clearance for Fluid Management During Hemodialysis

Courtesy of Fresenius Medical Care.

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Fresenius Medical Care, a major player in the kidney care medical industry, announced on March 14, 2019 that the FDA has granted approval for software to help fluid management during hemodialysis. The software will be designed to work with newer Fresenius Medical Care hemodialysis machines using the CLiC™ device.

Fluid management is a critical concern for dialysis patients, as both fluid overload and fluid depletion are associated with adverse cardiovascular events, morbidity and mortality. Working with the CLiC device which enables relative blood volume monitoring (RBV-M), the new software aims to create a dialysis machine with embedded intelligent diagnostics that will provide computer-assisted recommendations for achieving target levels of RBV.

“This new software represents our commitment to driving innovation and aims to become an essential tool in reducing cardiovascular events for people living with kidney failure,” said Mark Costanzo, president of Renal Therapies Group, the technologies and pharmaceuticals division of Fresenius Medical Care North America. “Effective fluid management is critical to creating the best hemodialysis treatment possible for each individual. We are proud of this effort to further advance our proven Crit-Line technology.”

According to iData Research, the overall dialysis market in the U.S. is currently valued at $1.93 billion in 2019, and is expected to increase over the forecast period to reach $2.1 billion.  The dialysis patient population has been increasing since 2013 and is projected to continue increasing over the forecast period. Notable trends include shifts between hemodialysis patients and peritoneal dialysis patients as well as the rate of transition from in-center treatment options to personal, home treatment.


For Further Information

More on the dialysis device market in the US can be found in a series of reports published by iData Research entitled the US Market Report Suite for Dialysis Devices and Concentrates.

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