Fresenius Medical Care’s VersiHD with GuideMe Software OK’ed

Fresenius Medical Care (FMC) has gained U.S. Food and Drug Administration (FDA) 510(k) clearance for its VersiHD with GuideMe software, which is a self-guided interface for FMC’s VersiHD home hemodialysis (HHD) system.
 
The company said the software offers graphical walk-through guidance to boost ease-of-use and confidence for patients and nurses. It was designed to improve patient training time, make the transition to home dialysis easier, and give new users an easier training experience.
 
VersiHD with GuideMe software will become available in selected markets this year, FMC said, with existing VersiHD systems made available for upgrade.
 
“With over 13,000 HHD patients in the U.S. alone, we are excited to amplify the innovation NxStage offers with advanced technologies, like VersiHD with GuideMe Software,” Dr. Katarzyna Mazur-Hofsäß, CEO of Fresenius Medical Care’s Care Enablement segment, told the press. “We are committed to providing cutting-edge solutions to improve the health and well-being of dialysis patients by challenging the standard of home dialysis with the design of industry-leading products.”
 
Fresenius acquired the VersiHD platform from NxStage in a $2 billion deal completed in February 2019. NxStage has a record of over 30 million patient treatments at home over almost two decades. The company introduced the first portable HHD machine, NxStage System One, in 2005 with several iterations FDA cleared and released since.
 
“We expect VersiHD with GuideMe Software to further simplify home hemodialysis for patients during training and at home,” said Dr. Brigitte Schiller, Senior Vice President, Medical Officer, Home Therapies at Fresenius Medical Care. “As a result of this software upgrade, patients and their care partners will have additional support to be confident with the therapy at home. VersiHD with GuideMe Software will support Fresenius Medical Care’s mission of advancing access to home therapies to more patients.”