MARCH 12, 2012 ~ How bad are medical devices approved by the U.S. Food and Drug Administration? Reuters reports (here) that Consumer Reports believes they are very bad. The president of the 76-year-old publication wrote in an email to 1 million subscribers this year that, “The implant that fixed your knee or your heart may
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JANUARY 10, 2012 ~ The front-page headlines in Europe concern substandard and defective breast implants made by the French company Poly Implants Protheses (PIP) that ruptured and deflated leaking machine-grade silicone in the women who had the implants to enhance their appearance or to mask the effects of disfiguring breast surgery. Share this:

Medtronic is the world’s top maker of medical devices and it didn’t get that way without help. The U.S. Department of Justice accused the Minnesota-based company of having friends in high places – Share this:

The FDA is pushing back on an Institute of Medicine recommendation that the fast-track approval process for medical devices is fatally flawed and should be replaced, reports Reuters. FDA’s Jeffrey Shuren, director of the Center for Devices and Radiological Health, which oversees devices, said the 510(k) process should not be eliminated, but “we are open
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