Archive for July, 2011

FDA announces changes to fast-track approval process for medical devices

Filed July 28th, 2011 joshua

The Food and Drug Administration has drafted new guidance for when a medical device company must seek the agency’s approval on changes to a specific product after it has already been approved.
The draft guidance recently enacted by the FDA namely speaks to medical devices which have been approved using the agency’s 510(k) fast-track approval system. […]

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California woman sues Medtronic and Stryker after failed back surgeries, blames illegal use of bone growth products

Filed July 21st, 2011 joshua

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FDA warns of possible radiation overdose with certain cardiac PET scans

Filed July 21st, 2011 joshua

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Doctor at Center of Stent Scandal Loses License

Filed July 15th, 2011 Julie

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FDA Says 2,800 Side Effects Linked to Transvaginal Mesh

Filed July 14th, 2011 Julie

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Drug testing firm accused of fraud scheme in whistleblower lawsuit

Filed July 14th, 2011 joshua

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Johnson & Johnson May Face $1 Billion Liability over Recalled Depuy Hip Implants

Filed July 13th, 2011 Julie

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Medtronic issues warning on SynchroMed II drug infusion pumps

Filed July 12th, 2011 joshua

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DePuy Hip implant Lawsuits Piling Up

Filed July 8th, 2011 Julie

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Medtronic Takes Hit Following Infuse Revelations

Filed July 7th, 2011 Julie

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