FDA clears Fresenius dialysis machine

Monday, February 21, 2011
FDA clears Fresenius dialysis machine

By Michelle Lang

Fresenius Medical Care, a Waltham medical device company focused on renal therapy, has been granted clearance from the U.S. Food and Drug Administration for its 2008K@home dialysis machine.

The company said in a news release today that the newly approved hemodialysis machines are like Fresenius’ existing 2008 series machines but with a “simpler user interface.” The machines, made to help patients conduct hemodialysis treatment at home, are expected to be available commercially in late spring or early summer of 2011. Medical device makers have been taking initiatives to make devices for the home that are more user friendly.

Fresenius (NYSE: FMS) was founded in 1996 through the merger of Fresenius Worldwide Dialysis and National Medical Care.

Last October, Fresenius received a warning letter from the FDA indicating that the company’s facilities used to produce kidney dialysis devices were out of compliance with FDA standards. The FDA said the findings in the letter followed an inspection of the Waltham-based company’s plant between June 15 and August 6, 2010.

The company announced in January that its German parent company Fresenius Medical Care AG & Co. KGaA was planning a notes offering of $500 million in senior unsecured notes due 2021 and approximately $405 million of senior unsecured notes due 2021.

http://www.masshightech.com/stories/2011/02/21/daily3-FDA-clears-Fresenius-dialysis-machine.html