medical device

/Tag: medical device

Transvaginal Mesh and $800,000 Conflicts of Interest

Dr. Vincent Lucente Mesh News Desk, March 14, 2014 ~ Some of the names in this story may sound familiar, primary among them  Dr. Vincente Lucente. He was one of the doctors mentioned during the Linda Gross transvaginal mesh trial naming manufacturer Ethicon (Johnson & Johnson). Lucente was [...]

By |2018-07-30T13:20:43-04:00March 14th, 2014|Media Reports|6 Comments

When the Sales Rep is in the Operating Room

Gynecare Prolift, Medtechmarket.ru One of our very smart readers,  Jade, brought this article to my attention.  Imaging your doctor learning about a new medical device in a weekend cadaver clinic. Then image your doctor being schooled on use of the device, how to implant it for example, with [...]

By |2013-08-27T14:59:22-04:00August 27th, 2013|Media Reports|8 Comments

PBS "Need to Know" Friday, March 22 on FDA and Medical, Surgical Devices

Linda, Jeff Gross March 22, 2013 ~ Friday night, March 22, Public Broadcasting (PBS) looks into the U.S. Food and Drug Administration (FDA) oversight of medical devices and how so many enter the market with little review and oversight. The 510(k) process allows devices on the market after [...]

By |2013-03-22T13:06:04-04:00March 22nd, 2013|Media Reports|8 Comments

Fishing for Clients

WikiCommons, Scott Steiner December 15, 2012~ It's unfortunate.... women and men injured by mesh and medical devices receive will sorts of solicitations online.  Some claim to be the Watchdog of America, on your side, and  fighting for justice... Beware, many are legal referral services.   Basically they take your [...]

By |2012-12-15T00:00:00-04:00December 15th, 2012|Legal News|0 Comments

Most High-Risk Heart Devices Approved With No Tests

Heart Valve rings November 24, 2012 ~  Most readers of Mesh Medical Device News Desk are familiar with the ease with which surgical mesh and other medical devices make it to the market. An exchange of paperwork and a claim of 'substantial equivalence' to another device already being [...]

By |2012-11-25T00:36:17-04:00November 25th, 2012|FDA News|0 Comments

FDA Follows Industry Lead to Shorten Time to Market

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 [...]

By |2012-10-31T00:27:06-04:00October 31st, 2012|FDA News|1 Comment

FDA: How to Follow Medical Devices?

Public Invited to FDA meeting on Postmarket Surveillance Barcode, Wiki, author, Maly LOLek September 4, 2012~ Every modern day vehicle comes complete with a VIN number, an identifier number that stays with the car during its lifetime. If there is an auto recall the owner is notified and [...]

By |2012-09-04T11:17:50-04:00September 4th, 2012|FDA News|0 Comments

FDA’s Shuren Tells Industry Medical Device Reviews are Faster, More Efficient

Dr. Jeffrey Shuren, CDRH If you ask the public, most say they want safer medical devices, not more of them.  If you ask the patients profiled in Mesh Device News Desk (MDND) they’d say they wished they’d known that the medical devices they received had come with a [...]

By |2012-06-14T15:58:11-04:00June 14th, 2012|FDA News|1 Comment

New J & J CEO Plans to Expand Medical Device Industry

  It will be interesting to watch how Alex Gorsky, 51, handles his new job and all that comes with it. As of April 26, he is in charge of Johnson & Johnson (J&J) as its Chief Executive Officer. He also inherited a massive number of lawsuits from [...]

By |2012-04-30T23:35:11-04:00April 30th, 2012|Media Reports|0 Comments

History in the Making Petition by Meshies United UK Group

 Petition Delivered to 10 Downing Street I would like to introduce myself. My name is Teresa Hughes The Owner and Founder of The Meshies United Group in the United Kingdom. I originate from Liverpool, Merseyside, England the home of The Beatles and Liverpool Football Club. I had an [...]

By |2012-04-30T13:14:09-04:00April 30th, 2012|Op-Ed|58 Comments