| November 13, 2009 | News for medical technology professionals |
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- Hamburg says FDA working to address problems at device unit
FDA Commissioner Margaret Hamburg said the agency is seeking a new chief for the device unit and is working to address issues related to the division, including a formal review of the 510(k) process. "There have been some questions raised about the appropriateness of the approvals of medical devices, and that's going to get a hard look. That's fine, it should," said Michael Mussallem, AdvaMed's chairman and CEO of Edwards Lifesciences, at the Reuters Health Summit. Reuters
(11/12)
      
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- Edwards CEO: Devices to face pricing pressure from hospitals
As potential health care reform seeks to curb rising medical costs, hospitals could put pressure on the prices of medical devices and that could be "more intense in the future," said Michael Mussallem, Edwards Lifesciences' CEO and AdvaMed's chairman. Mussallem also noted that the proposed cuts in Medicare payments would pose a negative effect on the device industry. Reuters
(11/12)
- Expert says RBMs helped slow imaging growth
Data from the top five radiology benefit management companies showed that the use of advanced imaging modalities, such as PET, MRI and CT, decreased or stalled in several states where they operate, said Dr. Vijay M. Rao, radiology chair at Thomas Jefferson University Hospital in Philadelphia. More than 15,000 of the 404,612 requests for CT, MR or nuclear imaging tests were either canceled or changed in 2008, RBM firm HealthHelp said. "The data clearly show (RBMs) have been effective," Rao said. Diagnostic Imaging
(11/12)
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| Science & Health |  | |
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- Study: Adhesive speeds up recovery from open-heart surgery
A procedure that uses "Kryptonite," a special adhesive developed by Doctors Research Group, to fix broken breastbones following open-heart surgery, expedited the recovery of patients and substantially eased their pain and discomfort, a Canadian scientist found. The study also showed that the surgical technique was able to reduce the use of pain drugs. Yahoo!/Reuters
(11/12)
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| Government & Regulatory | | |
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- Health reform could boost mergers in device sector, J&J exec says
The medical-device industry is likely to see more mergers and acquisitions if the proposed industry tax in a health reform bill "puts more pressure on smaller med-tech companies," said Dominic Caruso, Johnson & Johnson's chief financial officer. Speaking at a conference, Caruso said the company plans to continue acquiring device firms as well as pursue buyouts and partnership deals in the field of consumer health products and pharmaceuticals. The Wall Street Journal/Dow Jones Newswires
(11/12)
- Some CME firms resist proposal to disclose drug, device donations
Some companies that provide continuing medical education for doctors are opposing a health reform measure that would require firms to report payments to physicians and third parties. Funding from the industry goes to classes that do not include specific products, in compliance with federal rules, said defenders of industry-aided continuing medical education. The Wall Street Journal
(11/13)
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Combination Products
Key present and former FDA staff and industry experts discuss important regulatory and practical issues related to combination products, including the new proposed rules on GMPs and postmarket safety reporting for combination products. More information. Medical Technology Learning Institute -- Education Beyond a Degree
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Sign up now for $250 discount
AdvaMed's MTLI is offering a $250 discount on all remaining 2009 courses. Full agendas and logistical information can be obtained on our Web site. In order to receive your discount, please contact Katia Kunze at (202) 434-7237. Some restrictions apply.
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