Fresenius Medical Care's Latest Achievement: Versi®HD with GuideMe Software Garners FDA Clearance

Thursday, August 24, 2023

Fresenius Medical Care, renowned globally for its comprehensive offerings for individuals with renal ailments, has made a significant announcement. The company has received the coveted FDA 510(k) clearance for its latest product, Versi®HD with GuideMe Software. This innovative iteration marks a complete transformation of the self-guided interface for the VersiHD chronic home hemodialysis (HHD) system, with the potential to reshape the experience for patients and healthcare providers alike.

Drawing from its extensive experience of serving over 30 million patients at home over nearly two decades, NxStage from Fresenius Medical Care has firmly established itself as a leader in the HHD domain. With a footprint spanning more than 45,000 homes and catering to diverse water sources across the United States, NxStage's authority is unquestionable.

The standout feature of VersiHD with GuideMe Software lies in its intuitive graphical walkthrough guidance. This enhancement aims to simplify usability and bolster confidence, catering to both patients and healthcare providers. The objective is to streamline patient training, facilitate smoother transitions to home-based care, and render the training process more user-friendly, particularly for newcomers. Given the substantial population of HHD patients—exceeding 13,000 in the U.S. alone the introduction of such advanced technology, exemplified by VersiHD with GuideMe Software, is poised to amplify NxStage's pioneering efforts. The outcome is expected to significantly ease the process of home hemodialysis, aiding patients both during training and in their ongoing home-based treatment routines.

This software upgrade extends a vital layer of support to patients and their caregivers, instilling a sense of confidence in independently managing the therapy within the comfort of their homes. As a result, VersiHD with GuideMe Software aptly underscores Fresenius Medical Care's overarching mission of expanding access to home-based therapeutic options, ensuring a broader reach for patients in need.



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