Waltham, MA based Fresenius Medical Care has announced FDA clearance of its 2008k@home dialysis machine. As its name suggests, the system will allow patients to receive dialysis treatments from their homes, without requiring regular trips to a special dialysis facility. Fresenius plans to begin selling its new dialysis machine later this year.
From the press release:
"The 2008K@home offers the broadest range of dialysis prescription delivery, regardless of patient size or metabolic needs,” said Chief Medical and Regulatory Affairs Officer Jose Diaz-Buxo, MD, FACP. “It offers versatility and the reliability of many years of experience with this platform." The 2008K@home combines the known safety, efficacy and reliability of the 2008® series hemodialysis machines with a simpler user interface and additional new features specifically designed to facilitate home hemodialysis. 2008K@home incorporates all standard performance and safety features expected in modern hemodialysis machines.
Announcement: Fresenius Medical Care Receives FDA Clearance for 2008K@home™ Dialysis Machine…