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Tag Archives: FDA

Morcellator Activist, Victim Amy Reed Dies at 44

By Mesh Medical Device Newsdesk |

Mesh  Medical Device News Desk, May 25, 2017 ~ Drs. Amy Reed and Hooman Noorchashm put a public face on the failures of the U.S. Food and Drug Administration and how it regulates medical devices.  Amy Reed, the Philadelphia physician who put a public, tragic face on the outcome of unregulated medical devices has [continue reading…]

Does the FDA’s MAUDE Work?

By Mesh Medical Device Newsdesk |

Mesh Medical Device News Desk, May 17, 2017 ~ Does MAUDE work? MAUDE is the FDA’s central database that’s supposed to identify problems with medical devices that are on the market. Washington University did a review and found it was inadequate.  Printed on the website of Society of American Gastrointestsinal and Endoscopic Surgeons (SAGES),is [continue reading…]

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…]

Australian Investigation into Transvaginal Mesh Leads to Trials and Senate Inquiry

By Mesh Medical Device Newsdesk |

Mesh Medical Device News Desk, March 16, 2017 ~ Unlike the U.S. media,  Australian media is reporting on its transvaginal mesh debacle with citizens leading the charge. Transvaginal mesh devices seem to be front page news overseas. Joanne McCarthy writes for the Newcastle Herald, located about 100 miles north of Sydney, Australia. The paper [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…]

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