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FDA Grants Clearance to Versi HD With GuideMe Software
The FDA granted 501(k) clearance to Fresenius’ Versi HD with GUideMe Software. The device will be available in select markets at some point in 2023, and previous models will be upgradeable.
Versi HD With GuideMe Software
The FDA granted 501(k) clearance to Fresenius’ Versi HD with GUideMe Software. The device will be available in select markets at some point in 2023, and previous models will be upgradeable.
In a press release, CEO of Fresenius Medical Care’s care enablement segment Dr. Katarzyna Mazur- Hofsäß said, “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. 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."
The VersiHD provides users with visual aids during the hemodialysis process and is designed to be used by both nurses and patients. The device is meant to be easily trained on so that patients can use it themselves.
"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, also said in the press 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."
