Waltham, MA-based Fresenius Medical Care has received FDA clearance for its 2008K@home dialysis machine. According to the company, the device offers patients more options for achieving adequate dialysis in the comfort of their own home and will be available to patients in the late spring or early summer.
Fresenius' attempt to get in the home dialysis game puts it in direct competition with its neighbor 30 miles to the north, NxStage Medical, which makes portable dialysis machines, Mass Device explains. And Leerink Swann analyst Danielle Antalffy, who covers NxStage for the investment bank, called the move "clearly a negative headline" for the company in an email for investors, Mass Device reports. However, she pointed out that the 2008K@home was "large, not truly portable, and requires significant plumbing/electrical alterations in the patient's home."
Last October, it was revealed the FDA had sent a warning letter to Fresenius stating the company's facilities used to produce kidney dialysis devices don't conform to agency standards. The agency said the findings in the letter followed an inspection of the company's plant between June 15 and August 6, 2010.
- get the Fresenius release
- read the Mass Device report