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    Early Feasibility Studies for Devices: FDA Highlights Success From Pilot

    In a paper published in the Journal of Vascular and Interventional Radiology last week, two officials from the US Food and Drug Administration (FDA) say that the agency's early feasibility study (EFS) program helped optimize the development of a new type of catheter designed to prevent pulmonary embolisms. The program is part of an effort by FDA to promote more EFSs being done in the US, as device makers often conduct such studies elsewhere before conducting later stud...
  • US Regulators Issue Warning About Implantable Device

    The US Food and Drug Administration (FDA) issued a warning on Friday, 29 June regarding an implantable medical device manufactured by Covidien Plc subsidiary ev3's Onyx Liquid Embolic System , which federal regulators said has been associated with at least nine patients deaths and dozens of adverse events. The device is used to block the flow of blood in affected blood vessels in patients with brain arteriovenous malformations (AVMs) before the vessels are surgically re...