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# NxStage Medical Next Gen Hemodialysis System Cleared
- URL: https://www.fdaweb.com/nxstage-medical-next-gen-hemodialysis-system-cleared/
- Published: 2017-05-11T12:00:00.000Z
- Updated: 2026-09-14T22:23:04.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5138672

FDA has cleared a NxStage Medical 510(k) for its next generation hemodialysis system, NxStage System One. The device features a new touchscreen user interface and integrated blood pressure monitor designed “to enhance ease of use for patients performing home hemodialysis,” the company says. “The touch screen interface provides an excellent platform to continue bringing new features and functionality moving forward,” it adds.

  
NxStage says the device is the “only truly portable hemodialysis system cleared specifically by the FDA for home hemodialysis and home nocturnal hemodialysis. The simplicity and revolutionary size (just over a foot tall) are intended to allow convenient use in patients' homes and give patients the freedom to travel with their therapy. When combined with the NxStage PureFlow™ SL Dialysis Preparation System, patients are able to further simplify, using ordinary tap water to create dialysis fluid on-site on-demand.”