Posts Tagged ‘
Medtronic ’
Sep 26th, 2012 |
By Jane Akre
September 26, 2012 ~ With all of the news about complications resulting from transvaginal synthetic surgical mesh, and the thousands of product liability lawsuits filed in state and federal court, one might assume industry would push back. That’s exactly what is happening. The Pelvic Floor Disorders Alliance is launching a Public Awareness Campaign, “Break Free
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Posted in Media Reports |
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Tags: American Medical Systems, American Urogynecologic Society, AUGS, Boston Scientific, Break Free from PFDs, Matthew Barber, Medtronic, Merck Consumer Care, Pelvic Floor Disorders, Pelvic Floor Disorders Alliance, pelvic organ prolapse, PFD Alliance, POP, transvaginal synthetic surgical mesh, voices for pfd
Jun 20th, 2012 |
By Jane Akre
Next Wednesday, June 27 and Thursday, June 28, the U.S. Food and Drug Administration (FDA) will convene one of its expert panels – this one on patient complications after a metal-on-metal hip implant. It is a gathering called by the Orthopaedic and Rehabilitation Devices Panel of the Medical Devices Advisory Committee within the FDA. The
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Posted in FDA |
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Tags: 510(k), A.S.R, acetabular component, advisory panel, Ann Morrison, BBC, birmingham Hip Resurfacing, British Medical Journal, chromium, Class II, Class III, cobalt, DePuy, FDA, Howard Sadwin, Johnson & Johnson, Medtronic, metal ions, metal-on-metal hips, MoM, recall, resurfacing system, Smight & Nephew, total hip replacements, transvaginal mesh
May 24th, 2012 |
By Jane Akre
May 24, 2012 ~ The U.S. Food and Drug Administration (FDA) is one step closer to being funded for the next five years in a bi-partisan vote considered good for the FDA and industry – but what about patients? The Food and Drug Administration Safety and Innovation Act passed on an unusual bi-partisan vote, 96-1,
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Posted in FDA |
2 comments
Tags: AdvaMed, Consumers Union, FDA, Food and Drug Administration, Food and Drug Administration Safety and Innovation Act, MDUFA, medical device industry, Medtronic, National registry, PDUFA, Safe Patient Project, user fees
Feb 9th, 2012 |
By Jane Akre
An article in DOTmedNews reports that GOP freshmen are aligning with industry to oppose a 2.3 percent excise tax on the medical device industry set to go into effect January 2013. Industry says it will hurt profits and drive jobs and innovation oversees. As the deadline gets closer, the opposition is growing louder. Monday, February
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Posted in Feature |
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Tags: excise tax, Medical Device Innovation Act, Medtronic, Minnesota, Rep. Erik Paulsen, St. Jude
Dec 18th, 2011 |
By Jane Akre
Artificial hips that fail, surgical mesh that injures – the New York Times reports (here) on December 14, 2011, that amid the growing number of problems with medical devices a bipartisan bill was introduced in the U.S. Senate that would require device makers follow the life of their products after they’re approved for sale. Share
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Posted in FDA |
3 comments
Tags: Advanced Medical Technology Association, Boston Scientific, CR Bard, DePuy, FDA Law, Greg Borri, Guidant, Institute of Medicine, Johnson & Johnson, Medical Device Patient Safety Act, Medtronic, PMA, vaginal and hernia mesh, Zimmer Holdings
Dec 18th, 2011 |
By Jane Akre
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:
Posted in Media Reports |
1 Comment »
Tags: Department of Justice, Infuse, kickback, Medtronic, Minnesota, payments, Reuters, Shuren
Nov 12th, 2011 |
By Jane Akre
NOVEMBER 12, 2011 – Fridley, Minnesota is home to Medtronic, the largest medical device company, and an article in the Star Tribune, November 12, Saturday, asks Did Medtronic sell an unsafe product? (here) Share this:
Posted in Media Reports |
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Tags: conflict of interest, Congress, Infuse, kickbacks, Medtronic, off-label
Nov 8th, 2011 |
By Jane Akre
Understanding Barriers to Medical Device Quality is the name of an FDA report issued October 31 by the Center for Devices and Radiological Health (CDRH) and the Food and Drug Administration (FDA) in an attempt to get a handle on why the medical device industry is putting out poorly made, defective medical devices that are
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Posted in FDA |
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Tags: 510(k), Adverse events, CDRH, FDA, Hernia Mesh, Johnson & Johnson, Medtronic, mesh complications, Recalled Mesh, substantial equivalent