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Articles from 2007 In February


Breaking News: MDUFMA Reauthorization Negotiations Nearing End

Transforming FDA LogoAccording to Janet Trunzo, executive vice president of regulatory affairs at AdvaMed, the end of negotiations for the next version of MDUFMA is near. Speaking at the annual meeting of the American Institute for Medical and Biological Engineering this morning, Trunzo told attendees to expect a press release about the proposal within days. The negotiations involving the user fee system have been between AdvaMed, FDA, and key members of Congress. MDUFMA must be reauthorized by the end of September, and there's been a lot of closed door discussion about how it should be restructured, along with whether any of the other provisions should be changed. Stay tuned for more information about the proposed agreement.

Crawford, Former FDA Commissioner, Sentenced and Fined

Philips and Intel Collaborate on Wireless Device

Equipped with a touch screen and digital camera, the device will be used to "identify staff and patients, fill out charts, capture vital signs, write up reports, and validate blood transfusions." The medical grade, sealed device will also monitor wound healing and be able to withstand sterilization. According to a Philips spokesman, the companies decided to collaborate as a result of Philips' experience with medical equipment used in hospitals and Intel's skill in manufacturing chips and other technology for mobile devices. The launch of the device has been planned for the fourth quarter, according to the Associated Press.

Scientists Develop New Prostate Cancer Test

They found that the higher the level of PSA density in a man, the more likely he will be later diagnosed with aggressive prostate cancer, even if nothing is showing up at the moment. Biopsies fail to identify between 20 and 33% of prostate cancers, because they sample a small section of the prostate. The test can identify a high-risk group that should probably receive multiple biopsies.

Bypass Making a Comeback?

But the American Heart Association and the American College of Cardiology never stopped recommending bypass surgery for patients with multiple blockages in two or more arteries. Yet because of the dramatic early success of drug-eluting stents, many such patients received stents instead of bypass surgery, even though the stents were approved for use in patients with simpler problems. It is patients with complex problems that seem to be most at risk from long-term stent use. So more of them are now getting bypass surgery, again. This may be an overreaction to last year's negative publicity, but then again, putting stents into some of these patients in the first place may have been an overreaction to 2003's positive publicity.

Allergan Acquisition Fights Obesity

The company already makes LAP-BAND, the only adjustable implant device for individual weight loss approved in the country. Allergan also manufactures a nonsurgical intragastic balloon that is used outside the United States to treat obesity. According to an article in the Red Herring, Johnson & Johnson will be providing some competition, as it's slated to enter the U.S. market with its Swedish Adjustable Gastric Band this year. Its subsidary Ethicon Endo-Surgery has already  made the product available in Europe.

Lilly Unveils Insulin Pen with Memory

To combat this, Lilly is offering coupons for more than half off the price of the pen.

Juror Sees Trends Emerge in MDEA Process

Ogan Gurel, MD, writing at midwestbusiness.com, notes these broad trends: good design leads to product success; simplicity and going back to the basics are to be encouraged; medical product function is increasingly being driven by software, and over-engineering it can be perilous; and devices that can minimize or eliminate errors are most valuable.

Orthopedists Debate Need for Gender-Specific Products

The piece quotes some anonymous orthopedic surgeons as saying they don't think Zimmer's Gender Solutions artificial knee is truly better for women, or at least not enough to justify the price (which is almost twice the cost of other knees), but that they will implant them upon request. Zimmer CEO Ray Elliott says that the female knee's benefits are scientifically valid, and that it has exceeded sales expectations and fueled a 23% earnings bump in the fourth quarter. Zimmer expects to roll out a female hip later this year.

Stents Can Take Shape of Arteries

At MD&M West, Secant Medical, LLC (Perkasie, PA) is exhibiting a technology that could solve that problem. It has developed small vascular grafts that contain a stent inside, built into the structure and constructed with Nitinol, a metal with shape-memory capabilities. The graft materials and the Nitinol allow the stent to curve and twist in accordance with the actual shape of human veins and arteries. But, says Ryan Haniford, a Secant R&D engineer, the product has not caught on yet with the big stent companies. What are they waiting for?