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Tag Archives: University of Minnesota

Study of Medical Device Rules Is Attacked, Unseen, New York Times, July 27, 2011

By Mesh Medical Device Newsdesk |

Allies of the medical device industry criticized an Institute of Medicine report, to be released July 29, that says the approval process for a wide range of medical devices such as hip implants, hospital pumps, surgical mesh and external heart defibrillators is deeply flawed, is injuring patients and causing numerous injuries, reports the New [continue reading…]

Sen. Al Franken (D-MN)

510(k) Reform: Minnesota Congressional Delegation Lines up in Opposition, Mass Device, August 3, 2011

By Mesh Medical Device Newsdesk |

Sens Amy Kloubechar (D-Minn.), Al Franken (D-Minn.) and Rep. Erik Paulsen (R-Minn) reject calls by the Institute of Medicine to kill the 510(k) program that allows medical devices on the market without premarket approval. In a joint statement the lawmakers rejected a July 2011 Institute of Medicine findings that the FDA should scrap the [continue reading…]

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