Medical devices

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*New* Power Morcellator Controversy Spurs FDA Proposal – But Does it Go Far Enough?

Power morcellator graphic, WSJ The Wall Street Journal (WSJ) reports on Friday the House passed a bill that would improve the safety monitoring of medical devices. It was inspired by a gynecological device - the power morcellator. The morcellator is a tool that is used to grind up [...]

By |2015-07-13T15:50:30-04:00July 13th, 2015|FDA News, Morcellator Injuries|0 Comments

Consumers Union: Manufacturers Should Warranty Knees and Hips

Your big screen television and new car comes with a warranty- why not the most important medical purchase you will make in your life? Consumers Union, an arm of Consumer Reports, has come up with a novel and common sense approach. Manufacturers of medical devices should warranty their products. They [...]

By |2013-09-12T11:01:09-04:00September 12th, 2013|Medical News|3 Comments

FDA Asks Consumers to Report Product Failures

June 10, 2013 ~ New and Improved? The U.S. Food and Drug Administration (FDA) is celebrating 20 years of the MedWatch program by providing consumers with a new form that should encourage consumers and medical professionals to report adverse events, complications and bad outcomes with drugs and medical devices, cosmetics, [...]

By |2013-06-10T16:07:02-04:00June 10th, 2013|FDA News|4 Comments

FDA Helps Industry Push Medical Device Innovation

Medical Device Innovation Consortium logo December 4, 2012 ~ The FDA will collaborate with the medical device industry it regulates in a public-private collaboration, all to speed up the approval of new devices. The newly formed nonprofit group,  Medical Device Innovation Consortium (MDIC), has a goal of speeding [...]

By |2012-12-04T20:45:09-05:00December 4th, 2012|FDA News|1 Comment

The FDA’s Internal Employee Struggles

November 26, 2012 ~ The U.S. Food and Drug Administration (FDA) is a large public agency that regulates consumer products that make up about $1 trillion in annual spending or 25 cents of every dollar spent on food, cosmetics, drugs, medical devices and tobacco products. The Partnership for Public Service [...]

By |2012-11-26T15:34:19-05:00November 26th, 2012|FDA News|0 Comments

FDA Whistleblower Case Moving Ahead

November 13, 2012 ~Round one in the FDA whistleblower scandal goes to the U.S. Food and Drug Administration. Regulatory Focus (here) reports the FDA had a minor victory November 9, in its case against the National Whistleblower Center (NWC) which is representing five both current and former employees of the [...]

By |2012-11-13T22:43:22-05:00November 13th, 2012|FDA News|1 Comment

The Scandal of Defective Medical Device Approval in UK

Deborah Cohen, BMJ investigator October 28, 2012 ~ Working with undercover reporters from The Daily Telegraph in the UK, the British Medical Journal's (BMJ) Deborah Cohen has exposed, "a fragmented, poorly regulated, market driven system, with financial incentives to prioritize manufacturers’ interests over those of patients, and with [...]

By |2012-10-29T00:12:52-04:00October 29th, 2012|Media Reports|2 Comments

ProPublia: Four Medical Devices that Bypassed FDA Scrutiny

May 10, 2012 ~ ProPublica, an independent journalism organization, reports on four medical devices that are among the thousands pushed into the marketplace every year that do not undergo Food and Drug Administration (FDA) scrutiny. The bottom line - medical devices are big business bringing over $100 billion-a-year [...]

By |2012-05-10T16:05:00-04:00May 10th, 2012|Featured|2 Comments

Politics Gives a Pass to Negligent Doctors, Drug and Device Makers

March 20, 2012 ~ The advocacy group, Public Citizen in a letter (here) to Congress issued Monday, March 19 calls on the U.S. House to Reject the medical liability bill called H.R. 5. The House may vote this week on the legislation called the Help Efficient, Accessible, Low-Cost, Timely Healthcare [...]

By |2012-03-20T12:55:38-04:00March 20th, 2012|Legal News|2 Comments

Sen. Grassley Comes to Defense of One Whistleblower in Letter to Hamburg

February 9, 2012 ~ “Whistleblowers point out fraud, waste and abuse when no one else will, and while they do so while risking their professional careers, they are often treated like skunks at a picnic,” Grassley wrote. “Whistleblowers have played a critical role in exposing harmful government actions [...]

By |2012-02-08T15:50:07-05:00February 8th, 2012|Featured|0 Comments