U.S. Food and Drug Administration
Baxter and DEKA Announce FDA Acceptance of Investigational Device Exemption for Home Hemodialysis System
Published in Medical Letter on the CDC and FDA, December 5th, 2010
2010 DEC 5 -- Baxter International Inc. (NYSE:BAX) announced that the U.S. Food and Drug Administration (FDA) has approved an Investigational Device Exemption (IDE) application for a Home Hemodialysis (HD) system in development through a collaboration between DEKA Research and Development Corp., HHD LLC, and Baxter. The IDE approval allows the companies to initiate a clinical study in patients undergoing hemodialysis treatment.
"This regulatory milestone is an important step in our efforts to advance the care of patients with end-stage renal disease," said Carlos Alonso, president of Baxter's global Renal business.
"We are gratified to...
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