Wednesday 25 April 2012

FDA fast-tracks three new technology products

FDA announces plans to pilot end-stage kidney disease technology in new program

Innovation Pathway aims to reduce time and cost of bringing safe and effective, breakthrough technologies to patients.

Three products for patients with end stage renal disease (ESRD) have been chosen to participate in the FDA’s Innovation Pathway, an evolving system designed to help medical devices reach patients in a safe, timely and collaborative manner.

The FDA selected three from 32 product applications ranging from an artificial kidney to devices that assist kidney function that were submitted in response to a January 2012 request from FDA’s device center.

The three products 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.

The majority of the 32 applications came from small, start-up business or academic institutions.

The ESRD products will be the focus of the second version of the Innovation Pathway, first announced in 2011, to shorten the time and cost it takes for the development, assessment and review of medical devices, in particular breakthrough medical devices.

ESRD is the progressive loss in kidney function over a period of months or years. The kidneys play an essential role, filtering and removing waste from the body and producing hormones that are responsible for calcium absorption and red blood cell production.

The FDA chose ESRD because more than half a million Americans suffer from the disease. Management of the disease is largely dependent upon medical device technology, such as hemodialysis (process for removing waste products) equipment.

This info is from a recent press release by the FDA