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Articles from 2006 In April


FDA Revises Postmarket Surveillance Guidance

Doctors Call for Sweeping Change in Heart-Device Safety Monitoring

These suggestions, it said, could remove financial considerations from deliberations about when to communicate safety issues and commence recalls.  We certainly don't need another Guidant fiasco, and having more voices heard on these matters can only be a positive. But it's completely unrealistic to expect financial issues to hold no sway. Particularly naive is the statement that "single adverse events that could cause death or serious injuries in patients merit notification" if the problem is likely to recur. It would likely be very difficult to make generalizations based on one event, and it would be even more difficult for the mainstream media to report it with the proper perspective. Media-induced hysteria based on incomplete information would have serious financial consequences for the firm, and that is not something that can be removed from consideration. 

Is It Really Necessary to Replace Recalled ICDs?

That, not the problems themselves, was the most unseemly part of last year's Guidant debacle. The company kept selling the problematic models after it was aware of the malfunctions and made improved versions available.

MDUFMA Survey Reveals Dissatisfaction

But the message is the same: Serious changes must occur when MDUFMA is reauthorized. Update: The report is back online and can be found here.

Boston Scientific's Credit Rating Slashed

Moody's Investors Service, Standard & Poor's, and Fitch Ratings made the rating cut because of the debt Boston Scientific is taking on to finance the deal, and because of the legal liability it inherits from Guidant over faulty internal cardioverter-defibrillators. We probably won't be seeing Boston Scientific buying anything else for a while.

Boston Scientific-Guidant Deal Gets Final Approval

Guidant's stent business is being sold to Abbott Laboratories, which is paying $4 billion in cash and acquiring $1.4 billion worth of Boston Scientific stock. The FTC is requiring Abbott, whose participation helped alleviate antitrust concerns, to sell the stock within 30 months. Now on tap are some of the most daunting tasks ever faced in the device industry: The first-ever integration of two giant firms, and the placating of CDRH, which has had serious issues with both companies in the past year. Inability to pull off the latter could compromise the firm's ability to introduce new products.

Silicone Breast Implant Research Questioned

However, the center says, the Dow study attributes the difference to smoking, but the NCI study does not, and it does not rule out implants as a possible cause. The NCI study also found higher rates of suicide for the silicone-implant users. Another study, the center says, found high levels of platinum in the breast milk of women with silicone implants. These findings could make FDA's pending decisions on silicone implants even more difficult.

Positive Earnings News for Device Giants

saw profits rise 3% despite a (mostly drug-related) decline in sales. And the news was even good for Boston Scientific Corp. despite its reports of a 7% decline in earnings due to slowing drug-eluting stent sales. Its stock price rose because profits exceeded analyst expectations.

Medical Design Excellence Awards Announced

Gold and Silver designations will be announced at a ceremony on June 7 at the Medical Design & Manufacturing East show in New York City. In the meantime, read MD&DI's extensive coverage of the winners of this important competition.

Hearing and Visual Aid All in One?

That's because they intensify the sounds coming from the direction that the user is facing, due to their position on his or her face. The product's not yet on the U.S. market but who knows what kind of reception it could get.