Regulatory/Compliance
FDA | Recalls | 510(k) | Pre-Market Approvals | MDSAP | Clinical Trials
Hip Study: Smith & Nephew touts study results for new metal-on-metal implants
British orthopedic titan Smith & Nephew (NYSE:SNN) touted the results of a 10-year study of its metal-on-metal hip resurfacing implants, hoping to differentiate its implants from the high-profile recall of rival DePuy’s ASR device.
Device trials — more women needed
The FDA is considering a new, non-binding guidance that would encourage companies to include more women in their medical device clinical trials. A new article in the Journal of the American Medical Association by Sanket Dhruva and Rita Redberg of the University of California at San Francisco offers this example to show its necessity:
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.
MassDevice.com +3 | The top 3 med-tech stories for March 12, 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.
Protecting against radiation contamination: The Japanese nuclear reactor explosion a year later
By: Kelly Garnick
Breast implants: FDA clears new silicon implant despite consumer protests | Regulatory Roundup
MassDevice.com +7 | The top 7 med-tech stories for the week of March 5, 2012.
Say hello to MassDevice +7, a bite-sized view of the top seven med-tech stories of the week. This latest feature of MassDevice.com’s coverage highlights our seven biggest and most influential stories from the week’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 this weekend, make sure you’re still in the know with MassDevice +7.
Diabetes: Abbott lands FDA win for touch-screen glucose monitor | Regulatory Roundup
On Medtronic’s most recent medical device “correction”
Yesterday, Medtronic, Inc, the world’s largest medical device manufacturer, notified me in clinic about another problem with one of their lines of defibrillators via a Dear Doctor letter (1 Mbyte) headed by the line "URGENT: MEDICAL DEVICE CORRECTION."
It seems this term is now commonly seen on other Medtronic device advisories as well.
Inside the FDA: Keeping the focus on scientific integrity
By: Jesse L. Goodman, M.D., M.P.H.
Science, both its quality and its integrity, is key to everything we do at FDA. As a physician and researcher, science has always been central to the decisions I make at the bench or at the bedside. And now as the Chief Scientist for FDA, my office works across the agency to support our scientists and their cross-cutting scientific and public health efforts – and to help ensure that our decisions are science-based and protect and promote the health of the American people.