The Medical Device Business Journal — Medical Device News & Articles | MassDevice
Veteran cardiologist Dr. Robert Hauser is eager for change, even if he has to go straight to Capitol Hill himself to make it happen.
The patient safety advocate and vocal critic of the FDA announced at this year’s American College of Cardiology conference that he’s working on a proposal to fundamentally change the way federal regulators monitor medical devices and drugs once they hit the market.
St. Jude Medical (NYSE:STJ) called for a retraction of a study by a prominent cardiologist attributing 22 deaths to short circuits in its Riata defibrillator leads.
It figures. I head out of town and the cardiovascular news world erupts:
Dick Cheney gets a heart transplant
St. Jude Medical‘s (NYSE:STJ) troubled Riata defibrillator leads were tied to 22 deaths related to short-circuits between high-voltage components, according to study conducted by the Minneapolis Heart Institute.
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.
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Updated March 7, 2012, at 1:30 p.m. with comments from GE Healthcare.
MASSDEVICE ON CALL — GE Healthcare (NYSE: GE) announced another round of layoffs at its South Burlington, Vt., facility, a move it said is a result of declining demand for health care IT and performance solutions businesses.
The move is the "subsequent action" of layoffs numbering around 50 workers at the same facility last month, GE spokesman Corey Miller told MassDevice.
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 ON CALL — The problems with St. Jude Medical’s (NYSE:STJ) recalled Riata defibrillator leads should have been caught sooner, according to a prominent heart doctor.
Dr. Robert Hauser, of the Minneapolis Heart Institute, in an article for the New England Journal of Medicine, wrote that problems with the leads, which remain active in an estimated 79,000 U.S. patients, went uncovered for too long because of lax post-market surveillance.
Physicians from the Minneapolis Heart Institute Foundation and the Mayo Clinic will huddle with electro-physiologists in the Twin Cities Jan. 20 to discuss strategies for dealing with the recall of the Riata defibrillator leads made by St. Jude Medical Inc. (NYSE:STJ).
The FDA slapped the St. Paul, Minn.-based cardiology device maker with a Class 1 recall for the Riata leads in December, after the company said they failed more frequently than previously reported.
