B-Balloon Ltd., Medical Ventures Corp., and Neovasc Medical Ltd. have combined to form Neovasc Inc., a firm focused on specialty vascular devices. According to read more >>
July 2nd, 2008
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Johnson & Johnson's Ethicon Inc. has received an offer from a private equity firm for its wound care business, njbiz.com reports. Financial terms were not disclosed. The unit, which makes among other things Promogran wound dressing and the Regranex gel for foot ulcers, had $270 million in sales last year. Ethicon gave One Equity Partners the exclusive right to acquire the unit after fielding bids from several suitors. The unit's 800 workers would transfer with the business as part of the sale.
July 1st, 2008
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The Baltimore Sun has published an article about how FDA has stepped up its efforts to diagnose and prevent coding errors in medical device software. Of last year's 23 Class 1 recalls, three occurred because of software problems. And with the increased automation of software, there isn't as much human intervention with it as there used to be. So that means that it may be easier for software errors to go undetected, and to remain that way for longer, potentially putting patients at greater risk. There is a technological solution, but it is expensive, and most firms have not yet followed FDA's lead in adopting it. The human brain does not have the power or the patience to pore over an entire code and determine all possible outcomes. But a technology called static analyzers can. They were originally developed for rocket science. FDA learned in 2006 that they can be used for medical devices,...
July 1st, 2008
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With current mammography technology, it can be difficult to detect breast cancer in women who have dense breast tissue. This is significant -- about half of women under 50 and a third of women 50 or older are estimated to have dense breasts. And such women have a higher risk of getting breast cancer to begin with. MRIs are expensive and ultrasounds aren't proven to help. But two new imaging methods may help, reports the Associated Press. One is Stereo Mammography from BBN Technologies. It takes two X-rays at slightly different angles. Radiologists wear glasses that make each eye see a separate image on special monitors. It appears to the brain as a single three-dimensional view. In one study, stereo mammograms increased detection of breast cancer by 23% and reduced false positives by 46%. The other is Molecular Breast Imaging, being tested...
July 1st, 2008
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The New York Times on Sunday printed a long, long, long article about the overuse of CT heart scans. It says that while they are much more expensive than older methods of heart imaging, they have not been proven to be more effective. Yet doctors, especially those in practices that have invested in the machines, are eager to use them anyway. The article goes on to blame "the American devotion to the newest, most expensive technology" for rising healthcare costs. And once again, the Times rages about the alleged inadequacies of the 510(k) process. While people in the device industry may not take these sorts of conclusions seriously, undoubtedly there are politicians and opinion leaders who will. So it's important to pay attention to pieces like this.
June 30th, 2008
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The Medical Device Safety Act of 2008 would overturn the "federal preemption" clause in the 1976 Medical Device Amendments that allowed Medtronic to win a Supreme Court case earlier this year. AdvaMed late yesterday issued a statement against it. "A patchwork approach to medical device approvals where state courts effectively review and regulate medical devices would likely result in a dizzying array of conflicting labeling and indications for use and ultimately may result in life-saving, life-enhancing technologies simply not being available for patients," said AdvaMed President Stephen J. Ubl. The case, Riegel v. Medtronic, concerned a patient who was injured by a Medtronic catheter in 1996. The 1976 law stated that makers of PMA products cannot be sued in state courts if the products did not violate federal laws and regulations. It established FDA as...
June 27th, 2008
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Regulators in California have read more >>
June 26th, 2008
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A group of patients who have been harmed by complications from surgical mesh have formed an advocacy group, Truth in Medicine. One of its aims is to move surgeons away from synthetic meshes, which it says cause more harm than doctors and device companies let on, and towards biocompatible ones. According to Lana Keeton, one of the founders of the group, its goals are: * To stop the implantation of all petroleum-based synthetic medical meshes in humans. To get Congress involved because it is unlikely the device industry would take the initiative on its own. * To require changes in surgical consent forms regarding implantable foreign bodies to include: the name of the implantable; whether it was a PMA or 510(k) product; results of clinical trials, if any; and all known risks and complications. * To provide patients, upon discharge, with adverse event reports that...
June 25th, 2008
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Today's The Journal of the American Medical Association includes a study that points to the possible dangerous effect of RFID devices on critical care medical equipment. The physician authors concluded that these devices resulted in "potentially hazardous incidents" in medical devices in a controlled nonclinical setting. It also suggested onsite EMI testing be conducted when using RFID devices in a critical care environment, along with updating international standards. "The intensity of electronic life-supporting medical devices in this area requires careful management of the introduction of new wireless communications such as RFID," the authors note. Devices that were tested included external pacemakers, defibrillators, infusion pumps, anesthesia devices, and mechanical ventilators. The tests were performed in a nonclinical setting, and incidents of EMI were put into categories of hazardous, significant, or...
June 25th, 2008
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The Office of Device Evaluation annual report released Monday shows that CDRH was much faster in reviewing PMAs in fiscal year 2006 than in FY 2005, Reuters reports. The report attributed the improvement -- PMA reviews dropped from an average of 438 days in FY '05 to an average of 335 days in FY '06 -- to reforms implemented from the Medical Device User Fee and Modernization Act of 2002. Statistics for FY 2007 are not yet available. However, average 510(k) review time rose slightly, from 87 days in FY '05 to 95 days in FY '06. And the report also noted that third-party reviews dropped in 2007, compared to 2006. That was before reforms to the program included in the FDA Amendments Act of 2007 were implemented, though.
June 24th, 2008
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