FDA approves trial for wearable artificial kidney

February 10 2014

ATLANTA — The U.S. Food & Drug Administration has approved the start of the first human clinical trials in the United States for the wearable artificial kidney designed by Beverly Hills, Calif.-based Blood Purification Technologies Inc. The announcement was made by Victor Gura, MD, during the opening session on Sunday of the Annual Dialysis Conference taking place in Atlanta.

The device was one of three products related to end-stage renal disease that were awarded a special fast-track to market status in April 2012. The program, called Innovation Pathway, is a new system designed to help medical devices reach patients in a safe, timely, and collaborative manner. An implantable Renal Assist Device (iRAD) being developed by the University of California, San Francisco, and a Hemoaccess Valve System (HVS) designed by Greenville, S.C.-based CreatiVasc Medical were also awarded FDA fast track status

Original article: http://www.nephrologynews.com/articles/110030-fda-approves-trial-for-wearable-artificial-kidney

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