Transforming FDA LogoFDA is experiencing a serious challenge in the face of a wave of imported product recalls, especially those coming from China. "We have to get a handle on it," said Gail Costello, acting director of FDA's New England District Office. Costello, who spoke at MassMEDIC's annual FDA Update event on Friday, implied that resources have been part of the issue when dealing with imported products. About 28% of FDA-regulated imports are medical devices and radiological health products. Product recalls, including those beyond medical devices, put a strain on FDA district offices. For example, there are normally about 5000 consumer complaints per year. During the pet recall last summer, FDA...
December 3rd, 2007
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A study in the New Enlgand Journal of Medicine says that read more >>
November 29th, 2007
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Device giant Covidien and software firm Questra announced that they have launched the first remote-update system for the electrosurgical market. The Valleylab Exchange Software Update System allows hospitals to remotely update the software on the ForceTriad energy platform. That means they should be able to easily expand its capabilities and add support for new surgical instruments. The software is updated through secure electronic communications via RS-232 ports. Updates can also be done over the Internet at the hospital. Previously, these sorts of systems had to be sent out in order to receive software updates. The new way has the potential for significant cost savings.
November 28th, 2007
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An FDA staff report recommends approval of Abbott's Xience drug-eluting stent, saying that it is safer than existing devices, reports Bloomberg News. The report comes in advance of this week's Circulatory System Devices Advisory Panel meeting. If the panel agrees with the staff, chances for approval become very high. The report said that over two years, patients with Xience were half as likely to die, suffer a heart attack, or need repeat surgery than patients with Boston Scientific's Taxus. It also advocated longer studies after approval to ensure the device does not cause blood clots over time. This is no surprise; post-approval studies of Class III devices are almost de rigeur by this point. UPDATE: On Thursday night Nov. 29, the advisory panel did indeed recommend Xience for approval.
November 28th, 2007
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Smith & Nephew has recalled 575 knee implants, mostly used and targeted for patients in Europe, because they contained higher-than-normal amounts of iron, reports Bloomberg News. The brands affected are TC-Plus, VKS, and RT-Plus, all marketed by a subsidiary, Plus Orthopedics. The products in question were manufactured in May and June. A company notice says the products should not pose any toxicity or biocompatibility dangers. This is the second recall for the firm this year; 185 hip implants were recalled in August.
November 27th, 2007
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Shoppers at Rite Aid drugstores in the West read more >>
November 26th, 2007
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Yesterday I paid a visit to Precision Medical Products, a contract manufacturer located in Pennsylvania. It has a state-of-the-art 106,000 sq ft facility opened in 2005. It enables the firm to perform just about every function needed for medical device manufacturing (except sterilization) in-house. You'd expect something like this from a large company, but PMP is relatively small compared to some of its competitors. So how were they able to pull it off? The story is very interesting. A predecessor company had been the primary manufacturer of a special kind of needles used for the smallpox vaccine, until the disease was virtually wiped out in the 1970s. But after 9/11, bioterrorism concerns came to the forefront, and the U.S. government decided it needed safeguards against a potential smallpox outbreak. Indeed, it decided that it needed to stockpile one needle for every American citizen. So it went to PMP, and despite its small size, the firm figured...
November 21st, 2007
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As part of its strategy to further focus on its arthroscopy portfolio, Smith & Nephew Endoscopy is selling its vascular business. According to Joe Metzger, the company's spokesperson, the business segment has fewer than 20 employees and generates less than $5 million in annual sales. The Boston Globe is also reporting job cuts aren't planned. Investor group InaVein LLC picked up the vascular business for an undisclosed amount.
November 20th, 2007
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Boston Scientific and the ECRI Institute have read more >>
November 19th, 2007
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At least when it comes to treating abdominal aortic aneurysms (AAA). Did you know that deaths as a result of AAA are just as common as those from prostate and breast cancer? New tools are raising the bar in terms of what doctors can do, making good surgeons excellent and excellent surgeons phenomenal ones, according to Mark Farber, a physician who spoke at a media and investor event held by Cook Medical yesterday afternoon in New York City. Cook is one of three major companies leading the way in treating AAA. In fact, the company has exceeded its own expectations in global sales this year and now leads the worldwide market in endovascular aortic repair. By the end of the third quarter, Cook surpassed Gore and captured 40% of the U.S. market (Gore had 35% and Medtronic held 23%). In Europe, Cook took the top spot in AAA stent grafts at 42%. The company is working on several projects for its Zenith Endograft product family for 2008. We can expect to see several clinical trials, PMA...
November 16th, 2007
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