pacemakers

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 …

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 …

Could Medtronic become the next Guidant? The medical device maker warned Tuesday of a defect that could cause wires its Sigma brand pacemakers to separate from their circuits. Article

Guidant released a 153-page report containing detailed information about its defibrillator and pacemaker lines in an attempt to restore confidence in its products. The data appears to back the company's argument that faulty leads, not defibrillators or pacemakers, were to blame for some recent problems. The report also includes additional specifics about device failures and outcomes, details which the company has refused to reveal in the past. Some cardiologists welcomed the move. …

Guidant Corporation announced that it will sue Johnson & Johnson in an effort to force the completion of the merger of the two companies. The news came on the same day at that the SEC announced it will investigate the circumstances surrounding Guidant's recall of its faulty defibrillators and pacemakers. The device maker also released 3Q numbers which show just how bad things have gotten. Guidant's earnings are down to $795 million for the quarter, a drop of 14 percent. The company …

Guidant said it plans to regularly release data on its pacemakers and defibrillators in an effort to address safety concerns. The Indianapolis-based device maker has been the focus of attention since reports earlier this year that it failed to inform regulators about problems with its popular Ventak Prizm and Contak Renewal implants. This week, the company announced it is the subject of a Department of Justice probe into the circumstances surrounding its recall of both models. Over the …

The Justice Department has launched an investigation into possible violations of anti-fraud and anti-kickback laws by leading medical device manufacturers. Medtronic, Guidant and St. Jude Medical are the focus of an investigation headed by the US attorney's office in Boston into possible improper payments made to doctors. With competition in the market for defibrillators and pacemakers intense, some critics have questioned the tactics companies use to win customers. In September, The …

Johnson & Johnson is probably not planning on backing out of its merger with Guidant, according to insiders close to the transaction. Instead the company wants to renegotiate the $24.4 billion price tag it agreed on earlier for the Indianapolis-based device maker. The tough tactics may backfire, however, and lead to a legal battle between the two companies. The clear factor behind the decision, according to most analysts, was this summer's recall of 88,000 defibrillators and nearly …

Guidant paid doctors to participate in an evaluation of a new component that works with its pacemakers and defibrillators, a practice which some critics say raises ethical issues. The New York Times reports that the company paid doctors a fee of $1,000 if they agreed to implant a new version of a lead that connects its implant to the heart and complete a survey detailing their reactions to the technology. According to critics, Guidant's goal was to boost sales of its most …

A new study by the nonprofit research group RAND concludes that the high costs of breakthrough technologies like new cancer drugs, more efficient pacemakers and new treatments for Alzheimer's could end up putting serious pressure on  Medicare and programs like it. Researchers examined the future cost of 10 new technologies and found that costs are likely to be extremely high. The team concluded, for example, that anti-angiogenesis drugs which fight cancer by intelligently attacking …