Posts Tagged ‘ Safety and Efficacy ’

FDA Follows Industry Lead to Shorten Time to Market

Oct 31st, 2012 | By
2 TYPES OF HIP  replacement total and resurfacing

October 30, 2012 ~    The FDA has issued the new rules for medical device makers to speed up the time it takes for medical devices to make it to market. Earlier this year industry agreed to pay $595 million over 5 years to the FDA as part of its operating budget. In exchange, the
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Four J&J Vaginal Meshes Named – Will Be Removed from Market

Jun 5th, 2012 | By
Gynecare Prolift, West Coast Medical Resources

June 5, 2012 ~ There is now more detailed information about the move by Johnson & Johnson (J&J) to stop the sale of four vaginal mesh implants. The four named meshes are: TVT Secur Prosima Pelvic Floor Repair System Prolift Pelvic Floor Repair System   Prolift MTM Pelvic Floor Repair System These are the four
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Suffering in Silence: Howard Sadwin’s Story of Metal-on-Metal Hip Failure

Mar 5th, 2012 | By
Howard before and after 300

Howard Sadwin is 65 years old and lives in Sarasota, Florida. Life has not been the same since a metal-on-metal hip implant in 2007. In fact, during his 10-month hospital stay, Howard’s doctor leaned over and whispered to him that Howard was dying. But Sadwin survived and today is fighting mad about the artificial hip
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Sound Medical Devices Act- Dems Want FDA to Block Approvals When Similar Device is Recalled

Feb 2nd, 2012 | By
Rep. Edward Markey

  February 1, 2012 ~ Bloomberg reports on a bill  introduced this week that would put the brakes on the approval of a medical device that claims to be similar to another approved device that’s been recalled or found to be defective. The bill was introduced by Democratic lawmakers including Rep. Edward Markey (D-MA) on
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