FDA Puts Artificial Kidney on Fast Track for Approval
The FDA will be piloting three products for the treatment of end-stage renal disease (ESRD), including an artificial kidney, as part of an ongoing program to expedite the availability of medical technology.
The wearable artificial kidney is being developed by Blood Purification Technologies Inc., of Beverly Hills, Calif. It was among 32 product applications submitted to the Innovation Pathway 2.0, a fast-track system for the approval of medical devices with a focus on ESRD. Under the program, developers will have the opportunity to openly collaborate and discuss their findings with the FDA.
The program also selected an implantable Renal Assist Device in development at the University of California, San Francisco, as well as a Hemoaccess Valve System designed by CreatiVasc Medical in Greenville, SC.
According to a press release, the FDA chose ESRD because its treatment depends on medical device technology, with Medicare alone covering 75% of ESRD health care costs.