Medtronic

/Tag:Medtronic

Biomedical Expert on Regulatory Parellels of Pelvic Mesh to Breast Implants, Federal Preemption and There’s No Medical Grade Mesh

William A. Hyman Biomedical expert MND, January 13, 2016 ~ Dr.William A. Hyman, a Biomedical expert has been brought in as a consultant in some pelvic mesh cases.  Dr. Hyman compares FDA's reclassification of POP (pelvic organ prolapse) mesh to class III as a parallel to breast implant reclassification.  Read more

By | 2016-01-13T17:02:04+00:00 January 13th, 2016|News|14 Comments

Industry-Backed Patient Group Supports Surgery, Treatment

Pelvic Floor Disorders Alliance 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 Read more

By | 2012-09-26T20:07:10+00:00 September 26th, 2012|Media Reports|0 Comments

Coming Up: FDA Expert Panel Weighs in on Metal Hips

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 Read more

By | 2012-06-20T00:12:08+00:00 June 20th, 2012|FDA News|1 Comment

Senate Passes FDA Funding Bill Minus Major Patient Safety Provisions

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 Read more

By | 2012-05-24T23:15:39+00:00 May 24th, 2012|FDA News|2 Comments

Industry Doesn’t Want Medical Device Tax, GOP Freshmen Help

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, Read more

By | 2012-02-09T13:05:19+00:00 February 9th, 2012|Featured|0 Comments

More Monitoring of Medical Device Implants After Market

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 Read more

By | 2011-12-18T23:40:02+00:00 December 18th, 2011|FDA News|3 Comments

Medtronic Pays $23 Million to Settle Doctor Kickback Charges

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 – Read more

By | 2011-12-18T06:11:08+00:00 December 18th, 2011|Media Reports|1 Comment

FDA: Medical Device Complications Growing Faster than Industry

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, Read more

By | 2011-11-08T03:55:31+00:00 November 8th, 2011|FDA News|0 Comments