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  • Regulatory NewsRegulatory News

    FDA Approves First PFO Occluder From St. Jude

    The US Food and Drug Administration (FDA) on Friday approved Minnesota-based St. Jude Medical’s Amplatzer PFO Occluder, which is intended to reduce the risk of a stroke for some patients who previously had a stroke. The device – which was marketed more than a decade ago under a humanitarian device exemption (HDE) but was voluntarily withdrawn by St. Jude in 2006 after FDA concluded that the target population for it was greater than 4,000 patients – is specifically for s...
  • Regulatory NewsRegulatory News

    FDA to Keep Device Advisory Committee Chair Despite Conflict of Interest

    The US Food and Drug Administration (FDA) has granted a waiver to allow the chairman of its Circulatory System Devices advisory panel to keep his position later this month despite a conflict of interest. Richard Page, chair of the Department of Medicine at the University of Wisconsin School of Medicine and Public Health, currently serves as chairman of the Circulatory System Devices advisory committee, which reviews and evaluates data concerning the safety and effective...