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FDA says CT scans can make medical devices malfunction

July 15, 2008 — 9:39am ET | By Anne Zieger
The FDA has issued a warning that some critical electronic devices may malfunction when patients get CT scans. In fact, CT scans may actually cause some medical devices to shock patients using them,... Read more...

FDA to tighten medical device safety regs

November 12, 2006 — 8:01pm ET

The FDA has announced plans to tighten up regulations governing several medical devices, including stents, pacemakers, implantable defibrillators and other medical devices it regulates. The move was prompted, in part, by concerns over last year's massive defibrillator recalls, which concerned more than 200,000 devices. Among other steps, the FDA would like to see devices marked with a unique …

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Boston Scientific announces recall, shares drop

June 26, 2006 — 8:01pm ET

Boston Scientific said it will recall one of its pacemaker models after an FDA report released last week suggested many of the units will eventually malfunction. The device maker's shares fell seven percent on the news Monday and are down midday Tuesday. CEO Jim Tobin said in a conference call that it may take 18 months to two years to correct problems with the pacemakers and defibrillator lines the company acquired in the Guidant deal this year. He also hinted the recall may not be the …

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SPOTLIGHT: Medtronic wins FDA approval for Concerto

May 18, 2006 — 8:01pm ET


With potential device failure very much in the public eye after last year's recalls, it seems logical that technology which allows doctors to remotely keep tabs on how pacemakers and defibrillators are performing would be popular. That's probably good news for Medtronic: The company won FDA approval for its Concerto/Virtuoso line of implantable defibrillators, which allow wireless data transfer from the devices via patient home monitoring units. Article

CMS mulls reimbursement cuts for cardiac devices

April 16, 2006 — 8:01pm ET

CMS is considering reducing Medicare reimbursements for implantable heart devices, a change that could be a painful hit for specialty hospitals and device makers, if it does in fact go through. The cuts would impact some of the most lucrative heart device categories on the market, including pacemakers, defibrillators and stents. CMS officials say the changes are necessary to eliminate loopholes that specialty hospitals had been exploiting. The agency is weighing reducing payments for …

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FDA to monitor heart device safety

April 6, 2006 — 8:01pm ET

The FDA said it will set up a team of outside medical experts to study the safety of heart devices currently on the market. The decision is a step in a new direction for the agency, which has historically relied on internal advisory panels to review the safety of drugs and medical devices. The announcement comes days before the release of a report by the Heart Rhythm Society, an influential cardiologists group, which is expected to recommend major changes in the way safety issues are …

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Panel chastises Guidant over recall

March 20, 2006 — 8:01pm ET

An independent review panel sharply criticized Guidant for its past handling of patient-safety issues. The panel said the company's response to evidence of serious defects involving its pacemakers and defibrillators was inappropriate. Guidant executives learned of the problems three years ago, but chose not to release the information. The group's report finds the company relied on engineers to make decisions about the release of safety information rather than turning to medical experts. …

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Lawsuit data reveals turmoil at Guidant

February 27, 2006 — 8:01pm ET

Last year, just as it was putting itself up for sale to J&J, device maker Guidant was the feature of a series of articles in The New York Times in which it was accused of poorly communicating about problems with its pacemakers to physicians. Eventually, several pacemakers were recalled. Note that replacing a pacemaker means expensive and painful surgery, so this was not a trivial decision.

Now the Times features some of the discoveries from one of a number of …

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The FDA warns Boston Scientific

January 26, 2006 — 8:01pm ET

The FDA warned Boston Scientific that quality control problems at six of its manufacturing facilities still need to be addressed. The FDA warned the company has not fixed "continuing serious deficiencies." In the worst case scenario, the warning could mean that the device maker might be prevented from introducing new products until changes are made to correct the problems. The warning came only hours after Boston Scientific closed its $27.2 billion merger with Guidant on Tuesday. Some …

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Guidant bid deadline approaches for J&J

January 23, 2006 — 8:01pm ET

Johnson & Johnson has until today to raise its offer for Guidant. Many analysts think its unlikely J&J will fork over more than the $24.2 billion it has already offered to beat a larger bid from Boston Scientific. But on the other hand, it is increasingly obvious how important Guidant's business could be to the company's future. J&J turned in final results for 2005 today, reporting so-so drug sales but great numbers from its medical device and diagnostic services units, with …

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