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Fresenius Awarded Breakthrough Device Designation for Software

The measure from FDA comes shortly after Fresenius completed its merger with NxStage.

Fresenius Medical Care hit a significant milestone last week with its software to enhance its line of hemodialysis machines. FDA granted breakthrough device designation to the  company’s computer-assisted ultrafiltration control software. The software is in development to improve fluid management during hemodialysis and personalize treatments.

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 ), Fresenius said the new software aims to create a dialysis machine with embedded intelligent diagnostics that will provide computer-assisted recommendations for achieving target levels of relative blood volume.

"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," Mark Costanzo, president of Renal Therapies Group, the technologies and pharmaceuticals division of Fresenius Medical Care North America, said in a release. "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."

Fresenius said a timeline for the final development and approval of the software remains uncertain given the nature of developing the technology. 

The breakthrough device designation comes on the heels of Fresenius finally completing the $2 billion acquisition of NXStage. MD+DI says finally, because Fresenius first announced it would acquire Lawrence, MA-based NxStage in August of 2017.

However, antitrust concerns took part in the delay and caused Fresenius and NxStage to sell off some assets to satisfy Federal Trade Commission.

“The closing of this transaction is an important milestone in enhancing our patients’ choice of dialysis treatment modality,” Rice Powell, CEO of Fresenius Medical Care, said in a release. “By combining NxStage’s capabilities with our broad product and service offering, we can help patients to live even more independently. In addition to broadening our product portfolio, this acquisition positions Fresenius Medical Care to benefit from the growing trend toward home-based therapies.”

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