FDA announced late last week that Advanced Medical Optics (Santa Ana, CA) has voluntarily recalled its Complete MoisturePlus Multi Purpose Solution for soft contact lenses. Consumers who use the solution should stop using it immediately and discard it. They should also replace their lenses and storage container. As a result of a Centers for Disease Control investigation, the solution has been linked to a rare, but serious, eye infection, Acanthamoeba keratitis, caused by a parasite. It found that users of the solution were seven times more likely to develop the infection than those who do not use it. A similar scenario last year caused Bausch...
May 29th, 2007
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A Minnesota-based plastic surgeon is developing a diagnostic tool with the intention of detecting a silicone breast implant rupture. The mention of the technology is buried deep within a New York Times story about FDA's requirements for patients with silicone breast implants to undergo routine MRI's and the disagreement about this condition shared by many plastic surgeons. About four pages into the piece, a small paragraph talks about this interesting technology. According to the read more >>
May 24th, 2007
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Legal action that takes place in the drug industry is an indication of areas where device companies need to be cautious. Although the device industry is quite adamant (as it should be) about the differences between drugs and devices, litigation is one area where we're beginning to see similarities. Experts at device conferences during the past year have emphasized that we're next and that it would be wise to look at what's happening to drug companies to see if these problems are present in your organization. Yesterday evening, the Associated Press reported about a subpoena received by the drug company Amgen Inc. over promotional "and other" activities. While not much details were given, it noted that the subpoena sought documents from Amgen's sales and marketing activities, medical education, clinical studies, pricing and contracting, license and distribution agreements, and corporate communications. Experts at a...
May 23rd, 2007
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Medtronic Inc. is beginning a large, randomized trial that will examine the safety of drug-eluting stents. The 8800-patient clinical trial will compare the company's zotarolimus-eluting coronary stent system (Endeavor) with J&J's sirolimus-eluting stent (Cypher). Medtronic enrolled the first patient in the study, called Protect, yesterday. The trial will look at overal stent thrombosis after three years. Other points of analysis will include a composite of death and nonfatal myocardial infarction. According to an investigator of the study, the trial is designed to give doctors the long term safety data that they've been needing.
May 22nd, 2007
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Two New England-based women's health companies are joining forces as Hologic Inc. (Bedford, MA) announced that it will be acquiring Cytyc Corp. (Marlborough, MA). The $6.2 billion deal is expected to be completed in the third quarter. The combined entity will be called Hologic and will carry the torch of both companies. Jack Cumming, chief of Hologic, said that the merger is about creating growth, despite the fact that it will save from $25 to $30 million each year. Their combined portfolio will range from breast and cervical cancer screening, diagnosis, and treatment, to osteoporosis to contraception.
May 21st, 2007
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The relationship between hospitals and the medical device industry needs more integration, proclaimed Mary Ann Hilliard, chief risk counsel for the Children's National Medical Center (Washington, DC) last week. Hilliard spoke at a risk management conference jointly held by AdvaMed, FDA, and Virginia Tech. The disconnected relationship causes problems when it comes to equipment use error among clinicians. Linking both industries would both improve processes and drive down errors. From Hilliard's perspective, although technology in hospitals is incredibly innovative, until there is collaboration between both industries, hospitals won't be able to reduce sentinel events. She suggested the presence of more human factors engineers and reliability experts in hospitals, especially when conducting root cause analysis. Another part of the solution is more transparency in sharing data--however, with current liability issues, this is a major challenge.
May 21st, 2007
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Brain-related illnesses generate more healthcare costs than any other therapeutic area—$1.1 trillion annually in the United States, noted Zack Lynch, executive director of the Neurotechnology Industry Organization (NIO). Lynch made his remarks to kick off the Neurotech Industry Investing and Partnering Conference, taking place May 17-18 in San Francisco. In 2006, neurotech products across these three sectors generated more than $120 billion in revenue with 10% growth. Despite its already large size, Lynch said neurotech is poised for large growth with several factors driving this demand. Primary among these, he said, is that neurotech companies address the largest unmet medical market. The total number of people affected by brain-related illnesses worldwide has reached more htan 2 billion people, which means that nearly one in three people suffer from a brain-related illness. “Major medical device companies like...
May 18th, 2007
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So maybe it’s not so strange to think of a patient as a washing machine. That is, it’s not a bad idea to give a patient the same kind of warranty that a washing machine or a television would have. That is what the Geisinger Health System group in Wilkes-Barre, PA is doing. A read more >>
May 17th, 2007
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Shelhigh Inc., which had its inventory of tissue-based implants seized by the government because of concerns over sterility, has gone to court to get them back, but the judge says he's not inclined to grant the company's wish, reports the Star-Ledger of Newark. The firm argues that it should be allowed to ship the products overseas because GMPs don't apply to products made for export. U.S. District Judge William J. Martini said he does not agree with that interpretation, but is giving Shelhigh more time to collect additional evidence. The company says it will likely be forced out of business if it can't sell the seized product. Update: On May 18 FDA issued a preliminary public health advisory about possible contamination of Shelhigh devices.
May 16th, 2007
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Bausch...
May 16th, 2007
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