Elana Receives FDA Approval For Lifesaving Bypass Device
Dutch medical device manufacturer, Elana bv, announced that it has received approval from the U.S. Food and Drug Administration (FDA) for a humanitarian device exemption (HDE), enabling a lifesaving cerebral bypass. Elana bv is a corporate spin-off from the University Medical Centre Utrecht, the Netherlands. Bypass "The Elana Surgical Kit may help those with a rare condition for whom there ...

FDA Hitting Milestones In Tobacco Law
Since the passage of the Family Smoking Prevention and Tobacco Control Act in 2009, the U.S. Food and Drug Administration (FDA) has met the ambitious implementation deadlines set forth in the law, the agency said at a congressional briefing hosted by the American Association for Cancer Research. Lawrence Deyton, M.S.P.H., M.D., director of FDA Center for Tobacco Products, reviewed the many ...