Guidant

Consultant and connectivity guru Tim Gee examines the future of connectivity in the medical device sector in a piece on healthcare IT for Medical Device Link. With both wireless applications and medical devices hot suddenly everybody wants to get into the act and traditional device makers are finding the field competitive. The real action may lie in the market for integrating wireless medical devices with electronic health records, an area where Emergin and legacy specialist …

With the pharmaceutical industry facing generic competition and biotechs running into the federal ban on stem cell research and other impediments, healthcare venture capital investment continues to flow into the medical device sector. Business 2.0 reports that 70 companies received $690 million in VC funding in the first quarter of this year, an increase of more than 60 percent over a year ago. The magazine talks with Mark Brooks of BA Venture Partners who notes that the relative …

The Heart Rhythm Society, a leading cardiologist's group, released a much-anticipated set of guidelines governing how the healthcare industry should handle medical device recalls. The group recommend methods of collecting safety data to catch potential safety problems. It also says manufacturers should engage outside experts to monitor the performance of their products. Among the specific changes is a call for better reporting on malfunctions and routine inspections in cases in which a …

A new study in the Journal of the American Medical Association concludes that patients who have surgery to replace potentially faulty defibrillators recalled by Guidant and Medtronic last year may actually be at more risk than those who leave them in. Researchers looked at data on so-called "explant" surgeries at Canadian hospitals after the recalls and found that 5.9 percent of patients developed complications considered "serious." Three patients died. In contrast, the risk of …

The Guidant deal has transformed the market for cardiac defibrillators, yet the future is far from certain for the sector. New powerhouse Boston Scientific must cope with a cooling market for defibrillators in the wake of last year's recalls and the threat of Medicare reimbursement cuts. There is evidence that the problems at Medtronic and Guidant have led many doctors to hold off on recommending the potentially lifesaving technology for patients, or at least adopt a more conservative …

The outlook appears to be bright for ICD maker St. Jude. The St. Paul-based device maker reported excellent first quarter numbers with sales up for its cardiology and atrial fibrillation products, as the company reaped the benefits of woes at rival Guidant. St. Jude says it plans a significant expansion of its sales force this year.

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> Microsoft has won a $36 million contract to upgrade Australia's e-health infrastructure and build a platform for the country's electronic medical record system. Article

> Guidant's first trial over one of its faulty defibrillators has been postponed. Article

> Johns Hopkins said it is removing …

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 …

> A  new study finds that many physicians are unhappy about the Bush Administration's pay-for-performance push. Article

> HHS Head Mike Leavitt told the Cleveland Plain Dealer that the administration plans changes to Medicare Part D next year. Among them a requirement that insurers answer calls within 30 seconds. …

> A congressional inquiry found that the healthcare system in New Orleans remains crippled seven months after Hurricane Katrina. The GAO released a study that finds only 456 staffed beds in the city. Article

> Sales of home diagnostic kits are surging, leading to criticism from some doctors. …