Posts Tagged ‘ medical device ’


Feb 26th, 2015 | By
biomaterial act

Petitioning U.S. House of Representatives This petition will be delivered to: U.S. House of Representatives REPEAL THE BIOMATERIALS ACCESS ASSURANCE ACT OF ’98 We, the undersigned, call on the United States House of Representatives to consider repealing the Biomaterials Access Assurance Act of 1998 and hold any supplier of raw material such as Dacron, Polytetrafluoroethylene
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Report Finds Doctors Still Using Power Morcellator Despite the Risks

Sep 22nd, 2014 | By

Months after the U.S. Food and Drug Administration (FDA) warned a medical device could spread deadly uterine cancer, many doctors and hospitals are still using it. The power morcellator made by Johnson & Johnson (J&J) was removed from the market after the FDA warned it could spread undetected uterine cancers. A report in the Wall
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Wall Street Journal: Transvaginal Mesh and $800,000 Conflicts of Interest

Mar 14th, 2014 | By
Prolift as sold on eBay

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 one of the young doctors brought under the wing of Ethicon to be a preceptor, or trainer
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When the Sales Rep is in the Operating Room

Aug 27th, 2013 | By
Prolift, Medtech Marketing

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 the sales rep in the operating room along with you,
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Pap Smears: A Technican Speaks Out About Problems and Profits

Jun 20th, 2013 | By
Mark Krause

June 20, 2013 ~Mark K. is a laboratory technician whose job it is to read PAP smears, the annual test recommended to screen for cervical cancer for most women. In a rare insider opinion, he shares with readers of MDND what he feels is not working. It is a rare look at what many rank
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PBS “Need to Know” Friday, March 22 on FDA and Medical, Surgical Devices

Mar 22nd, 2013 | By
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 the manufacturer requests clearance from the FDA and names a
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Fishing for Clients

Dec 15th, 2012 | By

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 email after you pour your heart out to them and
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Most High-Risk Heart Devices Approved With No Tests

Nov 25th, 2012 | By
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 sold, and a manufacturer can launch his product- even a
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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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FDA: How to Follow Medical Devices?

Sep 4th, 2012 | By
Barcode, Wiki, author, Maly LOLek

Public Invited to FDA meeting on Postmarket Surveillance 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 an auto dealership can easily identify a vehicle that might fall under
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