NxStage Medical Wins Expanded FDA Clearance for System One Home Hemodialysis System

NxStage Medical won expanded FDA clearance for its System One home hemodialysis system, clearing it for use without a care partner during waking hours.

The system received initial clearance in 2005 and a further clearance in 2014, but has always required a care partner to be present during hemodialysis.

NxStage Medical said it will provide additional patient training for the new indication.