NN&I Article NxStage’s new System One gets FDA approval

NxStage’s new System One gets FDA approval


NxStage Medical Inc.’s next generation System One hemodialysis system has received clearance from the U.S. Food and Drug Administration. The system consists of new features and capabilities, including a new touchscreen user interface and integrated blood pressure monitor designed to enhance ease of use for patients performing home hemodialysis.

The device was approved in Europe in March.

“Early customer and patient feedback in the UK on our next generation system has been very positive, validating many of the benefits we expected,” said NxStage President Joseph E. Turk. “We are very excited to bring these new features and capabilities that are designed to significantly improve our patients’ therapy experience to the US market. The touch screen interface provides an excellent platform to continue bringing new features and functionality moving forward.”

Home Dialyzors United

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