FDA to expedite reviews of kidney failure devices.

Bloomberg BusinessWeek (4/9, Edney) reported, "A wearable artificial kidney and two other devices to treat renal failure will get fast-track reviews under a program" the US Food and Drug Administration "say can cut the time it takes to get 'breakthrough' medical technology to market." The agency "chose the three devices -- a valve system, an implant and the artificial kidney -- from 32 applications competing to be in the expedited-review program, the agency said in a statement today." Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health said, "End-stage kidney disease is 'a natural fit given that patients have few options.'"

        "The Center for Devices and Radiological Health's 'Innovation Pathway' was first announced in February 2011 as a pilot program," The Hill (4/10, Pecquet) "Healthwatch" blog reports. "The pathway program works within the existing regulatory framework, the FDA explains, while engaging with innovators earlier in the process in order to shorten the overall time and cost it takes for the development, assessment and review of breakthrough medical devices and to improve how FDA staff and innovators work together."

        Modern Healthcare (4/10, Daly, Subscription Publication) quotes HHS Secretary Kathleen Sebelius, who said in a video statement, "Our goal was to shorten the time and cost it takes breakthrough medical devices to move through the pipeline from development to assessment to final review," and added, "It is beginning to create a culture that embraces change." The devices "selected from 32 applicants are an implantable renal assist device developed by the University of California at San Francisco; a wearable artificial kidney, by Blood Purification Technologies of Beverly Hills, Calif.; and the Hemoaccess Valve System, designed by Greenville, S.C.-based CreatiVasc Medical." Also covering the story is Reuters (4/10, Yukhananov).