Last year, FDA convened the device firms that make biliary stents and reminded them not to promote off-label uses. read more >>
January 22nd, 2008
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Singapore's Biosensors International Group announced that it has received a CE Mark for its BioMatrix drug-eluting stent, which will allow it to be sold in Europe, Reuters reports. BioMatrix is the first DES for which one firm owns the patents for the drug, the stent, and the bioresorbable polymer. This could enable the firm to have a financial turnaround; it posted a $3 million loss for the first half of its current fiscal year. Company officials say they expect the firm to post a profit in the next fiscal year. The firm also expects to expand sales in Asia after recently acquiring a Chinese device firm. Biosensors International was named one of MD&DI's 50 Companies to Watch in 2006.
January 18th, 2008
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Researchers at Wake Forest University have discovered that variations in five regions of DNA are indicators of whether a man will develop prostate cancer. They have developed a DNA test and formed a company called ProActive Genetics to sell it for under $300, reports the New York Times. The test could be the first step in a revolution in medical prognostication. While it is not a surefire predictor of who will actually come down with prostate cancer, it can identify who should have aggressive screening and who probably shouldn't bother. Of course, the potential is also there for it to lead to unnecessary surgeries. If handled correctly, the test could save money and lives down the road. But patients and doctors will have to consider its results carefully.
January 17th, 2008
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Stryker has received its second warning letter in less than a year over manufacturing problems that could lead to malfunctioning hip parts, Reuters reports. A warning letter posted yesterday on FDA's Web site (but issued on Nov. 28) outlined infractions at Stryker's Mahwah, NJ plant, including failure to fix quality problems. It cited complaints about "squeaking noises" from ceramic-based hip implants, and said additional surgeries to alleviate fractures and pain were needed for some patients. The firm says it has been working with FDA since July 2007 on the problems. Last March, Stryker received a warning letter for a plant in Ireland that also makes hip implants.
January 16th, 2008
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FDA yesterday issued a notice to healthcare practitioners with recommendations about how to prevent device fragments from breaking off and staying in a patient's body, and steps to take should it happen. It also encouraged use of the MedWatch system to report such events. CDRH receives nearly 1000 reports per year on adverse events related to unretrieved device fragments.
January 16th, 2008
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Recent research from the Rosalind Franklin University of Medicine and Science in Chicago has shown that if diabetics get "hot spots" on their feet, that is an early indication of foot ulcers, which can lead to foot amputation. Unfortunately, diabetes often causes foot numbing, so patients may not be able to sense "hot spots" before they turn into foot ulcers. A special kind of foot thermometer can help them stay on top of the problem, according to an Associated Press report. Inflammation, an indication of tissue injury, can be measured by an increase in temperature. And a sudden rise can mean that a foot ulcer is about to break out. Right now, there is only one foot thermometer on the market, the TempTouch, a handheld device, made by Xilas Medical Inc. But typically with mainstream media coverage, the firm isn't mentioned by AP until...
January 16th, 2008
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A sophomore from the Massachusetts Institute of Technology has won the Future Engineers Scholarship from Kelly Engineering Resources. Michaelle Mayalu, a mechanical engineering student who hails from Tuscon, AZ, won the $5000 educational scholarship on the basis of an essay she submitted, in which she relayed how her father inspired her to become an engineer. MD&DI was one of the sponsors of the contest.
January 15th, 2008
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Yes, according to the company's CEO, Jim Tobin, who calls Boston Scientific's future "brighter than it has ever been." Yesterday's Boston Globe points to the shedding of billions of dollars in debt and significant job cuts as signs of a comeback. Boston Scientific also anticipates that FDA will lift its warning letter by midyear, which will allow the company to introduce Liberte, the next generation of the Taxus stent. The company is predicting a three to five percent revenue increase and earnings per share by 18 to 20 percent. It'll be interesting to see if Tobin is right. Abbott and Medtronic are also expected to gain FDA approval for their own stents this year, and some analysts think this could reduce Boston Scientific's share of the drug-eluting stent market from around 50% to between 20 and 30%.
January 14th, 2008
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A federal judge read more >>
January 11th, 2008
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A groundbreaking test that recently received FDA clearance can detect 12 viruses and viral subtypes in a few hours. Created by Luminex Molecular Diagnostics Inc. (Toronto), the xTAG Respiratory Viral Panel is the first of its kind to be cleared by FDA and promises to alter how doctors diagnose respiratory viruses. The test can simultaneously detect types of influenza, adenovirus, viruses that cause bronchitis and pneumonia, metapneumovirus, parainfluenza (which can lead to respiratory infections), and rhinovirus (causes the common cold). Conventional testing for viruses often requires several separate tests that can take up to several days to provide a diagnosis. According to the company, the speed of the test will also prevent the unnecessary use of antibiotics that has contributed to the creation of superbugs.
January 11th, 2008
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