Johnson & Johnson confirms $2.5B hip lawsuit settlement, consumers group wants more
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.
Consumers Union calls for more stringent oversight of medtech | MassDevice.com 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.
FDA medical device ID program: Purchasers pleased, industry wary
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.
FDA user fee bill: The nay-sayers
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.
MassDevice.com +3 | The top 3 med-tech stories for May 21, 2012.
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.
MassDevice.com +3 | The top 3 med-tech stories for April 6, 2012.
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.
Advocacy group Consumers Union got it wrong on med-tech, report says | MassDevice.com 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.
U.S. poll shows “overwhelming” support for more oversight of medical devices
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."
Ban metal-on-metal hips, say U.K. researchers | MassDevice.com 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.
Consumer groups urge FDA to rescind 510(k) clearance for Aptus endostapler
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.
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