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Minneapolis Heart Institute

Profile of an FDA critic: Q&A with patient safety advocate Dr. Robert Hauser

March 11, 2013 By Arezu Sarvestani Leave a Comment

Dr. Robert Hauser

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.

Filed Under: Food & Drug Administration (FDA), Healthcare Reform, News Well Tagged With: 510(k) reforms, American College of Cardiology Conference (ACC), Boston Scientific, MassDevice Q&A, Minneapolis Heart Institute, Patient Safety, stjudemedical

St. Jude demands retraction of Hauser Riata report

April 6, 2012 By MassDevice staff Leave a Comment

Riata leads

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.

Filed Under: News Well, Recalls, Research & Development Tagged With: Minneapolis Heart Institute, stjudemedical

The week in review – vacation style

April 4, 2012 By MassDevice

By Westby G. Fisher, MD, FACC

Westby Fisher

It figures.  I head out of town and the cardiovascular news world erupts:

Dick Cheney gets a heart transplant

Filed Under: News Well, Recalls Tagged With: Cardiac Rhythm Management, Dr. Wes, Minneapolis Heart Institute, Organ Transplant, stjudemedical

Riata: St. Jude contests results of study finding 22 deaths from short circuits unrelated to exposed wires

March 28, 2012 By Arezu Sarvestani

Riata

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.

Filed Under: News Well, Recalls, Research & Development Tagged With: Cardiac Rhythm Management, Minneapolis Heart Institute, stjudemedical

MassDevice.com +7 | The top 7 med-tech stories for the week of March 5, 2012.

March 10, 2012 By MassDevice staff Leave a Comment

Plus Seven

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.

Filed Under: Mergers & Acquisitions, News Well, Recalls, Wall Street Beat Tagged With: Boston Scientific, Cameron Health Inc., Minneapolis Heart Institute, Moody's Investor Service, Plus 7, stjudemedical, Zimmer Biomet

GE Healthcare announces layoffs in Vermont | MassDevice.com On Call

March 7, 2012 By MassDevice staff Leave a Comment

Updated March 7, 2012, at 1:30 p.m. with comments from GE Healthcare.

MassDevice On Call

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.

Filed Under: Legal News, Medicare, News Well, Patient Monitoring, Recalls Tagged With: Cardiac Rhythm Management, Cardiac Sciences Corp., GE Healthcare, Layoffs, MELA Sciences Inc., Minneapolis Heart Institute, Nihon Kohden, On Call

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

March 7, 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: News Well, Recalls, Wall Street Beat Tagged With: Layoffs, Minneapolis Heart Institute, stjudemedical, Zimmer Biomet

St. Jude’s Riata recall evidence of nationwide issue, doc says | MassDevice.com On Call

March 6, 2012 By MassDevice staff Leave a Comment

MassDevice On Call

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.

Filed Under: Electronic Medical Records (EMR), News Well, Recalls, Research & Development Tagged With: Boston Scientific, Cardiac Rhythm Management, Clinical Trials, Hips, Knees, Minneapolis Heart Institute, stjudemedical

Cardiovascular leaders to huddle on Riata recall

January 13, 2012 By MassDevice staff Leave a Comment

Riata Lead Summit

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.

Filed Under: News Well Tagged With: Cardiac Rhythm Management, Mayo Clinic, Minneapolis Heart Institute, stjudemedical

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