September 2015 Advisory Committee to discuss Essure Safety and Effectiveness The FDA has been examining safety concerns about Essure raised by patients and cited in Medical Device Reports (MDRs). We convened a meeting of the Obstetrics and Gynecology Devices Panel of the Medical Devices Advisory Committee on September 24, 2015 to: discuss currently available scientific…

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September 1, 2016 Audiences: Laboratory professionals and State Health Laboratories who use Sciex (previously known as AB Sciex) mass spectrometers Health care professionals who rely on test results provided by Sciex mass spectrometers Medical Specialties: All specialties may be impacted but tests using mass spectrometers may be particularly common for Anesthesiology, Neurology, Pain Management, Medical…

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration [Docket No. FDA-2016-N-1660] Microbiology Devices Panel of the Medical Devices Advisory Committee; Notice of Meeting; Establishment of a Public Docket; Request for Comments AGENCY:  Food and Drug Administration, HHS. ACTION:  Notice; establishment of a public docket; request for comments. SUMMARY:  The Food and Drug Administration…

September 1, 2016 Dear Vascular Surgeons, General Surgeons, Cardiothoracic Surgeons, and Neurosurgeons: The FDA has recently received multiple adverse event reports associated with Baxter International Inc.’s Vascu-Guard Peripheral Vascular Patch (also referred to as the Vascu-Guard patch) during carotid endarterectomy (CEA). These reports from 2016 include intraoperative or postoperative bleeding and hematomas, some of which…

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  On August 23, 2016, the FDA published the final guidance on Patient Preference Information – Voluntary Submission, Review in PMAs, HDE Applications, and De Novo Requests, and Inclusion in Decision Summaries and Device Labeling. It outlines recommendations on patient preference studies that may result in valid scientific evidence and how stakeholders, including industry and…

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