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Category Archives: FDA News

FDA’s Shuren on Tightening Future FDA Review of High-Risk Devices

By Mesh Medical Device Newsdesk |

Mesh Medical Device News Desk, April 20, 2017 ~ FDA’s Jeff Shuren writes about how to serve two masters, public safety and the need of manufacturers for fast access to the marketplace for high-risk devices. Can anyone serve two masters? For seven years, Dr. Jeffrey Shuren has headed the Center for Devices and Radiological Health [continue reading…]

Trump’s FDA Pick Grilled on Priorities, Conflicts

By Mesh Medical Device Newsdesk |

Mesh Medical Device News Desk, April 6, 2017 ~ President Trumps selection of Scott Gottlieb reveals a health industry insider full of potential conflicts.  Dr. Scott Gottlieb was grilled during a confirmation hearing on Capitol Hill Wednesday and said his first priorities will include the opioid crisis. Gottlieb is a medical doctor who turned [continue reading…]

New FDA Head Selected by President

By Mesh Medical Device Newsdesk |

Mesh Medical Device News Desk, March 14, 2017 ~ According to the New York Times, Mr. Trump’s latest pick to head the FDA could undo decades of drug safeguards. Dr. Scott Gottlieb, M.D., 44, has ties to pharmaceutical and biotech companies and is a partner at a large venture capital fund, which funds medical [continue reading…]

FDA: Lapdog Enforcement on Reporting Adverse Events

By Mesh Medical Device Newsdesk |

Mesh Medical Device News Desk, March 7, 2017 ~ In mild mannered newly-issued language, The U.S. Food and Drug Administration (FDA) recommends that medical device manufacturers report adverse events to the agency, but it’s not legally enforceable.    This new regulation issued November 2016, updates 20-year-old regulations for medical device reporting (MDR). Guidance for [continue reading…]

GAO Report on Power Morcellators

By Mesh Medical Device Newsdesk |

Mesh Medical Device News Desk, February 10, 2017 ~ The GAO report on power morcellators finds there were 25 requests to market new power morcellator devices submitted to the FDA over a 23 year period, all were cleared for the marketplace.    The U.S. Government Accountability Office (GAO) has just issued a report (here) [continue reading…]

FDA Finally Reclassifies Pelvic Mesh Tools

By Mesh Medical Device Newsdesk |

Mesh Medical Device News Desk, January 16, 2017~ Pelvic mesh tools used to place and affix transvaginal mesh had been a low-risk FDA category alongside Band-aids. Because of injuries, it’s been placed in a class II or moderate-risk category.  Tools used to place transvaginal mesh have been found to cause injuries in up to [continue reading…]

FDA Pelvic Mesh Data – Are Thousands of Deaths Not Being Reported?

By Mesh Medical Device Newsdesk |

Mesh Medical Device News Desk, December 5, 2016 ~ A former FDA IT project manager left the agency to focus on patient safety and the numbers needed for true patient advocacy. Imagine 5.6 million pieces of data collected by the U.S. Food and Drug Administration (FDA) concerning adverse events, the FDA term for complications. [continue reading…]

Essure Birth Control Gets FDA’s Strongest Warning

By Mesh Medical Device Newsdesk |

Mesh Medical Device News Desk, November 15, 2016 ~ The U.S. Food and Drug Administration has approved a label change on Essure Birth Control that includes the strongest warning a device can carry.  Known as a Black Box warning, the label change will now clearly warn about the significant side effects associated with Essure, including [continue reading…]

FDA Covers for Device Makers, Keeps Injuries Under Wraps

By Mesh Medical Device Newsdesk |

Medical Device News Desk, October 20, 2016 ~ The system is supposed to be transparent.   Medical device makers are required to alert the U.S. Food and Drug Administration (FDA) when their products injure consumers or malfunction.  The FDA then theoretically alerts doctors who alert consumers. In rare cases, such as pelvic mesh, the FDA will [continue reading…]

ProteGen – The First Mesh, a 20 Year History

By Mesh Medical Device Newsdesk |

Mesh News Desk, July 25, 2016 ~ ProteGen – The Grandmother Mesh Of the sixty or so pelvic meshes that were or currently are on the market in the United States you may not have heard of the ProteGen mesh, a model designed and manufactured by Boston Scientific. The ProteGen was the first transvaginal mesh approved in [continue reading…]

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