FDA clears VersiHD with GuideMe software for home hemodialysis
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Key takeaways:
- The system features a graphical walk-through guidance tool to optimize patient training.
- VersiHD with GuideMe Software will be available in selected markets in 2023.
The FDA has granted clearance to Fresenius Medical Care for its VersiHD with GuideMe Software, a self-guided interface for the company’s VersiHD chronic home hemodialysis system, according to a press release.
“With over 13,000 [home hemodialysis] HHD patients in the U.S. alone, we are excited to amplify the innovation NxStage offers with advanced technologies, like VersiHD with GuideMe Software,” Katarzyna Mazur-Hofsäß, PhD, CEO of Fresenius Medical Care's care enablement segment, said in the release. “We are committed to providing cutting-edge solutions to improve the health of patients by challenging the standard of home dialysis.”
The system has a graphical walk-through guidance tool that may streamline the training process, particularly for new users. It focuses on optimizing patient training time and facilitating the transition to home-based therapy, according to the release.
“We expect VersiHD with GuideMe Software to further simplify home hemodialysis for patients during training and at home,” Brigitte Schiller, MD, FASN, senior vice president and medical officer at Fresenius Medical Care, said in the release. “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.”
The system will initially be available in selected markets in 2023 and existing VersiHD systems can be upgraded, according to the release.
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