Guidant

Medicare will pay for a potentially revolutionary test that will allow doctors to determine if patients will benefit from a defibrillator. Supporters say the non- invasive test, which measures heartbeat fluctuations, could lead to major changes in the market for cardiac rhythm management devices. Some analysts think the test could dampen the defibrillator market by eliminating people who don't really need the devices. Companies like Guidant, Boston Scientific and Medtronic, which have …

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. …

Under new legislation floated in Minnesota, medical device manufacturers could wind up paying the entire bill for a patient's treatment and rehabilitation when a pacemaker or defibrillator is recalled. Congressman Tony Cornish (R) introduced the legislation Monday, saying it is unfair for either Medicare or private insurers to have to pay for a device maker's mistakes. Leading device companies Medtronic, Guidant and Boston Scientific all have production facilities in the state. Device …

Medical device companies are winning venture capital funding that until recently had been going to biotech companies. Last year, VC investments in biotech and medical device companies rose to a five-year high of $6 billion, according to the annual MoneyTree Survey. Investment in biotech ventures fell 7 percent but rose 25 percent in medical devices. The Wall Street Journal reports that investors are betting the market for devices will continue to grow as the US population ages. …

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 …

Boston Scientific CEO James Tobin meets with FDA officials today to discuss concerns over quality control issues at several of the device maker's facilities. Last week, the FDA delivered a stern rebuke to the company, saying it has failed to correct deficiencies despite repeated warnings. Some Wall Street analysts have speculated that the regulatory problems could delay Boston Scientific's acquisition of Guidant. Not surprisingly, the company is adopting a conciliatory tone in its …

> Ominous news for Guidant as federal officials say they want more details on the company's recalls. Could the longest-running med tech soap opera be taking another twist? Article

> The Washington Post examines Web sites that allow users to select healthcare providers on the basis of their race, gender and orientation. …

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 elected not to raise its bid for Giant, making Boston Scientific the winner of the bidding war over the device manufacturer. Giant officially accepted the $27.2 billion deal this morning. Under the terms of the agreement, Boston Scientific agreed to sell off Guidant's vascular intervention and endovascular business to Abbott Laboratories to address a potential regulatory roadblock to the deal. The deal must still be approved by regulators.

- see this …

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 …