FDA launches expedited approval for kidney-disease devices

The three winning products announced Monday are: 

• an implantable Renal Assist Device (iRAD) being developed by the University of California, San Francisco; 

• a Wearable Artificial Kidney (WAK) in development by Blood Purification Technologies Inc. of Beverly Hills, Calif.; and

• a Hemoaccess Valve System (HVS) that has been designed by Greenville, S.C.-based CreatiVasc Medical.

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"The Innovation Pathway seeks to shorten the overall time and cost it takes not just for pre-market review, but for the development, assessment and review of breakthrough medical devices so these devices can get to the patients who need them sooner," the FDA said in a statement. "The pathway also seeks to improve how FDA staff and innovators work together."

The FDA chose end-stage renal disease for the program's next step because of the disease's cost to the healthcare system: more than half a million Americans suffer from the disease, with Medicare footing 75 percent of the $29 billion-a-year bill. Management of the disease is largely dependent upon medical-device technology, according to the FDA, such as hemodialysis equipment to remove waste products from the body.