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Consumers Union

Johnson & Johnson confirms $2.5B hip lawsuit settlement, consumers group wants more

November 20, 2013 By Arezu Sarvestani Leave a Comment

Johnson & Johnson confirms $2.5B DePuy hip lawsuit settlement

Filed Under: Legal News, Metal-on-Metal, News Well, Recalls Tagged With: Consumers Union, depuysynthes, Hips, Johnson and Johnson

Hips and knees: Consumers Union calls for no-cost revision warranties

September 10, 2013 By Arezu Sarvestani Leave a Comment

Hips and knees: Consumers Union calls for no-cost revision warranties

Patients undergoing hip or knee implant surgeries are entitled to more security than they’re getting, according to the Safe Patient Project of Consumers Union, the advocacy arm of Consumer Reports.

Filed Under: News Well, Orthopedics, Recalls Tagged With: Consumers Union, Hips, Knees, Patient Safety, Personal Injury

Consumers Union calls for more stringent oversight of medtech | MassDevice.com On Call

April 23, 2013 By Arezu Sarvestani Leave a Comment

MassDevice On Call

MASSDEVICE ON CALL — Consumer advocacy group Consumers Union submitted a letter to U.S. healthcare regulators, offering more than 11,000 signatures in favor of more stringent oversight of implantable medical devices.

CU urged the FDA to require that all high-risk medical implants undergo clinical testing vie the agency’s premarket approval process, rather than allowing them through via the less-stringent 510(k) pathway, which requires only that a device demonstrate that it’s "substantially equivalent" to a product already cleared by the FDA.

Filed Under: Food & Drug Administration (FDA), News Well, Recalls Tagged With: Consumers Union, Covidien, GE Healthcare, Lobbying, On Call, Oxitone, Patient Safety

FDA medical device ID program: Purchasers pleased, industry wary

July 5, 2012 By MassDevice staff Leave a Comment

FDA UDI example

The FDA’s UDI label example: Product name, expiration date, reference and lot nos., manufacturer information, barcode, details and illustration.

Medical tech industry stakeholders are showing mixed reactions to the FDA’s latest proposal for a system of unique device identifiers that can monitor medical devices for tracking and public health purposes.

Filed Under: Food & Drug Administration (FDA), News Well, Regulatory/Compliance Tagged With: AdvaMed, Consumers Union, Novation, Unique Device Identifier (UDI)

FDA user fee bill: The nay-sayers

May 25, 2012 By MassDevice staff Leave a Comment

Sen. Bernie Sanders

Sen. Bernie Sanders (I-Vt.) stood alone in rejecting the FDA user fee reauthorization act.

Not everyone was as thrilled with the U.S. Senate’s passage yesterday of the latest iteration of the FDA user fee bill as were the lawmakers who repeatedly lauded the bipartisan amity that led to a swift decision.

Filed Under: Food & Drug Administration (FDA), News Well Tagged With: Consumers Union, MDUFMA, U.S. Congress, U.S. Senate

MassDevice.com +3 | The top 3 med-tech stories for May 21, 2012.

May 21, 2012 By MassDevice staff Leave a Comment

Plus 3

Say hello to MassDevice +3, a bite-sized view of the top three med-tech stories of the day. This feature of MassDevice.com’s coverage highlights our 3 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.

If you read nothing else today, make sure you’re still in the know with MassDevice +3.

Filed Under: Food & Drug Administration (FDA), Legal News, News Well Tagged With: Consumers Union, MDUFMA, Poly Implant Prothèse, Response Biomedical Corp., Securities & Exchange Commission (SEC)

MassDevice.com +3 | The top 3 med-tech stories for April 6, 2012.

April 6, 2012 By MassDevice staff Leave a Comment

Plus 3

Say hello to MassDevice +3, a bite-sized view of the top three med-tech stories of the day. This feature of MassDevice.com’s coverage highlights our 3 biggest and most influential stories from the day’s news to make sure you’re up to date on the headlines that continue to shape the medical device industry.

If you read nothing else today, make sure you’re still in the know with MassDevice +3.

Filed Under: Legal News, Medicare, News Well Tagged With: Centers for Medicare and Medicaid Services (CMS), Consumers Union

Advocacy group Consumers Union got it wrong on med-tech, report says | MassDevice.com On Call

April 6, 2012 By MassDevice staff Leave a Comment

MassDevice On Call

MASSDEVICE ON CALL — Consumer groups are a frequent presence in discussions of medical device regulation, but one relative newcomer may have lost some points in its representation of how the industry operates in its regulatory environment.

Consumers Union, an advocacy arm of Consumer Reports, launched a charge for more stringent FDA oversight of the industry just over a year ago with its Safe Patient Project.

Filed Under: Mergers & Acquisitions, Neurological, News Well, Wall Street Beat Tagged With: Biomet, Consumers Union, depuysynthes, Johnson and Johnson, On Call

U.S. poll shows “overwhelming” support for more oversight of medical devices

March 22, 2012 By MassDevice staff Leave a Comment

Safe Patient Project logo

A new survey of U.S. consumers pits safety concerns against the need for product innovation, finding that the vast majority of respondents were more concerned about patient safety than about speeding devices to market.

Of 1,000 people polled, 82% responded that "preventing safety problems is more important than limiting safety testing in order to prevent delays and encourage innovation."

Filed Under: News Well Tagged With: 510(k) reforms, Consumers Union, MDUFMA

Ban metal-on-metal hips, say U.K. researchers | MassDevice.com On Call

March 13, 2012 By MassDevice staff Leave a Comment

MassDevice On Call

MASSDEVICE ON CALL — A team of U.K. researchers is calling for a ban on metal-on-metal hip implants, citing studies that demonstrate that they fail more often than other artificial hips, especially when used in women.

Filed Under: Legal News, Medicare, Mergers & Acquisitions, News Well, Recalls Tagged With: Consumers Union, Hips, Johnson and Johnson, OptiMedica Corp., Stryker, SuperDimension Inc., Zimmer Biomet

Consumer groups urge FDA to rescind 510(k) clearance for Aptus endostapler

February 29, 2012 By MassDevice staff Leave a Comment

Aptus Endosystems HeliFX

A group of consumer advocates demanded that the FDA heighten testing requirements for certain medical devices, taking exception to the agency’s 510(k) clearance of Aptus Endosystems Inc.’s HeliFX endostapling system.

Filed Under: 510(k), Food & Drug Administration (FDA), News Well Tagged With: Aptus EndoSystems Inc., Consumers Union, Endovascular

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