Regulatory Focus™ > News Articles > Device Innovation Pathway Tackles End-stage Kidney Disease

Device Innovation Pathway Tackles End-stage Kidney Disease

Posted 10 April 2012 | By Louise Zornoza

The US Food and Drug Administration (FDA) has selected three medical devices being developed for end-stage kidney disease for participation in its new Innovation Pathway, which provides the sponsors of the devices the opportunity to work collaboratively with the agency. 

The goal of the Pathway is to reduce the time and cost of bringing safe and effective, breakthrough devices to patients. The three devices selected for the end-stage kidney disease initiative 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.
  • A Hemoaccess Valve System (HVS) that has been designed by Greenville, S.C.-based CreatiVasc Medical.


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FDA Innovation Pathway

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