| December 6, 2007 | News for medical technology professionals |
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| | White Paper on Electronic Medical Device Reporting (eMDR) Available
The FDA is urging device medical device companies to voluntarily adopt the agency's electronic Medical Device Reporting (eMDR) process in anticipation of being required to do so as early as next spring. Find out what you will need to know to successfully have your MDRs transferred and approved electronically. Click here to request this free White Paper. | |
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| Business & Market Trends |  |  |
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- Bristol-Myers to sell Mass. medical imaging unit
Bristol-Myers Squibb Co. has announced plans to sell its medical-imaging division in Billerica, Mass., as its patent for Cardiolite, a radioactive compound used in tracking blood flow in the heart, is set to expire next year, a company spokesman said. The company intends to cut 4,300 jobs worldwide and might sell its wound-care products supplier ConvaTec and Mead Johnson Nutritionals business to cut expenses and reorganize. The Boston Globe (free registration)
(12/6)        
- Growing combo-product market needs regulation, expert says
The market for combination medical products is predicted to grow to almost $10 billion in 2009, prompting one expert to call for new regulatory guidelines for the products. Microtest President and CSO Dr. Steven Richter says the key problems facing manufacturers of combo products would be sterilization and the scale-up process because of quality-control measures. In-PharmaTechnologist.com
(12/5)        
- Consortium to establish security standards for EHRs
Nine medical companies have formed a consortium to produce a set of security standards for the protection of electronic medical records. The security practices, which will be managed by Texas-based Health Information Trust Alliance LLC, are expected to eliminate the need for auditing an organization's data protection practices, a CVS Caremark Corp. executive said. The Wall Street Journal (free content)
(12/5)        
| Science & Health |  |  |
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- Study: Cell transplant could help treat heart diseases
Transplants of skeletal muscle cells engineered to produce connexin 43 protein were found to reduce the risk of ventricular tachycardia in mice induced to have heart attacks. "If it can be repeated in humans it would be a breakthrough in the treatment of patients with heart disease and could save thousands of lives," an expert in vascular development said. BBC
(12/6)        
| Emerging Technologies |  |  |
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- Wireless patch allows continuous heart monitoring
Dutch researchers have developed a wireless cardiac patch that could help doctors continuously monitor heart conditions and record electrocardiograms of patients. The device, which features a circuit board used to detect and transmit electrocardiograms up to 10 meters, could also allow early detection of heart troubles in healthy people and immediate treatment of cardiac patients, the inventor said. M.I.T. Technology Review
(12/6)        
- Nanoparticles improve drug delivery, developers say
U.S. researchers say they've been able to implant nanoparticles in model tumors that can deliver drugs to surrounding tissues by remote control. A researcher said the nanoparticles, which also act as contrast agents for MRI, could help lessen the administration of chemotherapy and repeated scans in cancer patients. M.I.T. Technology Review
(12/6)        
| AdvaMed News |  |  |
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AdvaMed joins coalition seeking extension of R&D tax credit
AdvaMed has joined a coalition of innovators and developers to call on Congress to make permanent the research-and-development tax credit that was first ratified in 1981, and to provide parity in the formulation used in determining the percentage of credit that companies receive. The tax credit, which will expire at the end of December unless the extension is granted, provides much-needed assistance to companies engaged in R&D activities, which have increased 20% cumulatively each year since 1990. Read AdvaMed's complete statement.        
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Today: AdvaMed-MTLI Audio Conference teaches you how to work with FDA to develop policy
FDA policies inevitably change over time in response to shifting attitudes, new information or technologies, or evolving political directives. FDA cannot and should not make these changes alone: Industry input helps ensure that new policies are reasonable and well-informed, and achieve the least-burdensome level of regulation while protecting the public's health. Sometimes companies need to take a more proactive approach. This audio conference shows you how. Access program and registration information now.        
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