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Tag Archives: substantial equivalence

Heart Valve rings

Most High-Risk Heart Devices Approved With No Tests

By Mesh Medical Device Newsdesk |

November 24, 2012 ~  Most readers of Mesh Medical Device News Desk are familiar with the ease with which surgical mesh and other medical devices make it to the market. An exchange of paperwork and a claim of ‘substantial equivalence’ to another device already being sold, and a manufacturer can launch his product- even [continue reading…]

Consumer Reports May 2012

Consumer Reports: Dangerous Medical Devices

By Mesh Medical Device Newsdesk |

April 1, 2012 ~ The May issue of Consumer Reports (here)  features an investigation into synthetic mesh and artificial hips – medical devices that escape rigorous testing to assure safety. Tens of millions of Americans are living with medical devices and whether a defibrillator, artificial hip or surgical mesh, – 90 percent of those [continue reading…]

510k 231 wide

New England Journal of Medicine – Medical Devices – Balancing Regulation and Innovation

By Mesh Medical Device Newsdesk |

January 19, 2012 ~ In a letter to the Editor of the New England Journal of Medicine (NEJM), (here) January 19, 2012, Neil Feder, M.D. of the Project on Government Oversight writes about the 510(k) process that allows untested medical devices onto the market without premarket approval.

Dr. Rajamannan, Northwestern University

Money and Medical Devices – Not Even a Whistleblower Can Stand in the Way

By Mesh Medical Device Newsdesk |

OCTOBER 12, 2011 – MassDevice (here) reports on the firing of Dr. Nalini Rajamannan, an associate professor of medicine at Northwestern University, who blew the whistle on a fellow physician for failing to obtain consent from patients before implanting an experimental medical device he invented.

Dr. Jeffrey Shuren, CDRH

How to Speed Up Approval of Medical Devices?

By Mesh Medical Device Newsdesk |

OCTOBER 3, 2011 –  How to speed up the approval of a medical device that cannot claim it is substantially similar to one already on the market under 510(k)? On Friday, September 30, the Food and Drug Administration released a long-awaited proposed revision to the 510(k) clearance process that could speed up product reviews [continue reading…]

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