Think just because you’re getting a new medical device that it must be “new and improved”? According to an article by Barry Meier in The New York Times, it doesn’t play out that way for medical devices designed to be hip replacements. “New” isn’t always “improved.” The new metal-on-metal hip implants were considered by device [...]
GAO Concerned About Medical Device Approval Process
April 20, 2011 By Leave a Comment
The Government Accountability Office (GAO) has raised concerns about the approval process that high-risk medical devices undergo — or rather, don’t undergo — by the U.S. Food and Drug Administration (FDA). The federal watchdog group says the agency recently took steps to see if certain high-risk medical devices, such as artificial hips and external defibrillators, [...]
Regulators Have Bone to Pick with Medtronic Devices
April 19, 2011 By 2 Comments
Bone growth products by medical device giant Medtronic are in the regulators’ headlights. Medical devices like Amplify and Infuse that stimulate bone growth are now front and center on the radar screens of the U.S. Food and Drug Administration (FDA) and the Justice Department. Medtronic also makes other medical devices such as pacemakers and defribrillators. [...]
Sudden Popularity of Biotronik Medical Devices Investigated
April 6, 2011 By Leave a Comment
Medical device company Biotronik decided to play it big in Las Vegas. An article in The New York Times discusses how the little-known company aggressively overtook the market for pacemakers and defribrillators at Las Vegas’ University Medical Center a couple of years ago. Before 2008, its products were not used at the hospital; in 2010, 95% of [...]
