FDA approval

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

Customs agents appear to have stepped up seizures of shipments from Canadian Internet pharmacies since the launch of Medicare Part D, according to the Los Angeles Times. Most of the Canadian suppliers the newspaper contacted say the number of confiscations has risen sharply over the past month. "It's huge--we've had over 800 seizures in January, up from 15 in a typical month," one importer told the paper. Shipping prescription drugs into the country without FDA approval has always …

Verichip, the Delray Beach, FL-based maker of RFID chips, plans to raise as much as $45.8 million in an IPO in the second quarter. The company estimates the potential market for its implants to be as large as 45 million patients. Verichip is the only company to have won FDA approval to market a RFID product for human patients. The chip maker is a unit of Applied Digital Solutions, a security specialist. To date, relatively few patients in the U.S. have elected to get the implants, in part …

According to The New York Times, the growing popularity of carotid stents as an alternative to non-invasive techniques for the treatment of carotid blockages is raising questions. The procedure, which won FDA approval last year, is generally portrayed by device companies and surgeons as a low-risk operation. New data calls that argument into question. Critics like Northwestern University's Dr. Mark J. Albert also wonder if the procedure is driving healthcare costs up and …

A news study conducted by researchers at Tufts argues that quicker FDA approval times for new drugs has had little or no impact on drug safety. That argument runs counter to critics who in part blame looser rules for the jump in safety problems in recent years. Researchers at the Tufts Center for the Study of Drug Development found that in the 1980s, 3.2 percent of drugs approved for sale in the US market were recalled. The authors note that since the year 2000, that number has fallen to …

Following a day long meeting of leading cardiologists in Washington sponsored by the Heart Rhythm Society, Medtronic announced that it is considering making public the performance data on its defibrillators. No other major announcements came out of the meeting, but insiders say reporting rules changes are likely given concerns about the recent increase in defibrillator defects. A government study released at the conference found that the number of problems has risen sharply over the last …

Food and Drug Administration regulators expressed "general approval" yesterday of Chiron's efforts to fix problems at its Liverpool vaccine plant, potentially clearing the way for the return of Fluvirin to the US market in time for this year's flu season. Contamination problems at the plant a year ago helped cause a widespread vaccine shortage, leading to chaos at many hospitals, clinics and doctors offices and fears of similar problems this year. Cynics are noting, however, that it was …

Guidant is making its return to the market for defibrillators for patients with congestive heart failure. On Friday, the Indianapolis-based company won FDA approval for a fix for a defect which caused a small number of units to malfunction. The highly expensive devices, which cost around $30,000 each, were pulled from the market in June. Guidant shares rose in response to the news this morning, climbing 4 percent to $71.62 in morning trading.

- see this …

The government will not know until at least August if there will be a flu vaccine shortage this year.Hoping to avoid last year's problems, many doctors are placing their orders early, USA Today reports. Earlier this month, Chiron, the company at the center of last year's shortage, lowered its production estimate to 18-26 million doses from an earlier estimate of 25-30 million.  Industry analysts say much hinges on an inspection at Chiron's Liverpool plant scheduled for July. …

> Under a new plan announced today, Walter Reed would be shut down. Story

> Sanofi-Aventis submits the much awaited Acomplia for FDA approval. Story

> Group Health appears to hold the good cards in Seattle. …