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Home » FDA clears software for Fresenius home hemodialysis system

FDA clears software for Fresenius home hemodialysis system

August 23, 2023 By Sean Whooley

Fresenius Medical Care NxStage VersiHD with GuideMe software
The VersiHD system. [Image courtesy of Fresenius Medical Care]
Fresenius Medical Care announced today that the FDA granted 510(k) clearance for its Versi HD with GuideMe software.

The completely reinvented, self-guided interface serves Fresenius’ VersiHD chronic home hemodialysis (HHD) system. It aims to transform the experience of HHD for both patients and nurses.

Fresenius Medical Care’s NxStage designed VersiHD with GuideMe to provide graphical walkthrough guidance. It enhances ease of use and confidence for patients and nurses while improving patient training time. The company says it eases the transition to home and makes the training experience easier for new users.

“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,” said Dr. Katarzyna Mazur-Hofsäß, CEO of Fresenius Medical Care’s Care Enablement segment. “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 Medical Care’s NxStage initially introduced its VersiHD system in 2017. More than 95% of U.S. HHD patients use the NxStage HHD system, according to the company.

VersiHD with GuideMe will initially be made available in select markets this year. Fresenius plans to offer upgrades to GuideMe software for existing VersiHD systems.

“We expect VersiHD with GuideMe Software to further simplify home hemodialysis for patients during training and at home,” said Dr. Brigitte Schiller, SVP, 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.”

Filed Under: 510(k), Dialysis, Food & Drug Administration (FDA), Health Technology, Regulatory/Compliance, Software / IT Tagged With: Fresenius, Fresenius Medical Care

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About Sean Whooley

Sean Whooley is an associate editor who mainly produces work for MassDevice, Medical Design & Outsourcing and Drug Delivery Business News. He received a bachelor's degree in multiplatform journalism from the University of Maryland, College Park. You can connect with him on LinkedIn or email him at [email protected].

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