Most Clicked AdvaMed SmartBrief Stories
1. FDA panel schedules review for Stryker's Wingspan brain stent
AdvaMed SmartBrief | Feb 14, 2012
An FDA panel is scheduled next month to evaluate premarket and postmarket data on Stryker's Wingspan brain stent, which has been approved for use under the humanitarian device exemption program. MassDevice.com (Boston) (02/13)
2. Stakeholders testify before Congress about device user fees
AdvaMed SmartBrief | Feb 17, 2012
AdvaMed board member David Perez joined other industry experts, consumer groups and government officials in testifying on Wednesday at a hearing before the House Energy and Commerce Subcommittee on Health about the Medical Device User Fee & Modernization Act. The latest agreement between the device industry and the FDA calls for $595 million to be paid in user fees over five years. "Delays in product approval, inconsistency in the review process, and the resulting downstream effects on investment and innovation have undermined the competitiveness of our industry and harmed patient access to new treatments, diagnostics, and cures," Perez noted in his testimony. MassDevice.com (Boston) (02/15)
3. FDA OKs prostate cancer assay from Gen-Probe
AdvaMed SmartBrief | Feb 16, 2012
Gen-Probe has secured FDA approval for PROGENSA PCA3, which is billed as the first molecular assay designed to help evaluate whether men who previously had negative prostate biopsies need to undergo a repeat biopsy. Reuters (02/15)
4. Proposal to repeal device tax may be up for a vote this year
AdvaMed SmartBrief | Feb 20, 2012
A bill that would repeal the 2.3% medical device tax set to begin in 2013 has gained momentum in Congress, garnering 228 co-sponsors so far, said Rep. Erik Paulsen, R-Minn., a co-author of the measure. "I actually expect that this is going to move forward in the House sometime this year, hopefully sooner than later. That's a question that's up to leadership," he said. MassDevice.com (Boston) (02/17)
5. FDA panel to review HeartWare's cardiac pump in April
AdvaMed SmartBrief | Feb 15, 2012
An FDA advisory panel is set to meet April 25 to evaluate HeartWare's premarket approval application for its HVAD system, a left ventricular assist device tailored to end-stage heart disease patients awaiting transplants. The company's shares rose 2.4% on the news. MassDevice.com (Boston) (02/14)
6. 15-minute-old infant receives pacemaker at Stanford hospital
AdvaMed SmartBrief | Feb 17, 2012
An infant diagnosed in the womb with a severe heart disorder and who had the abnormally low heart rate of 45 beats per minute at birth was implanted with a pacemaker just 15 minutes after she was born. The device is expected to last the baby for approximately 10 years, according to doctors who performed the procedure at Stanford University's Lucile Packard Children's Hospital. Yahoo! (02/15)
7. Researchers develop blood test for the early diagnosis of cancer
AdvaMed SmartBrief | Feb 14, 2012
Israeli researchers have developed a blood test that uses infrared light to detect small changes in the blood of a person with cancer. The researchers said the test can detect the cancer before it spreads. Researchers hope to put the test, which detected cancer in about 90% of patients in a study, into clinical trials within two years. Monsters and Critics (02/13)
8. Cordis exec to take CMO role at HeartFlow
AdvaMed SmartBrief | Feb 17, 2012
Campbell Rogers is resigning his chief scientific officer position at Cordis, a Johnson & Johnson unit. Rogers will assume the chief medical officer role at HeartFlow, a Redwood City, Calif.-based startup that is working on technology that can spot fractional flow reserve noninvasively through CT scans. MassDevice.com (Boston) (02/15)
9. Greatbatch pays $12 million to acquire NeuroNexus
AdvaMed SmartBrief | Feb 20, 2012
Implantable medical device design company NeuroNexus Technologies has been acquired by Greatbatch for about $12 million in cash, plus future payments and debt financing. Ann Arbor, Mich.-based NeuroNexus focuses on the development and sale of high-value neural interface tools, systems and components tailored to the clinical and neuroscience markets. Reuters (02/17)
10. Covidien makes headway in India with new R&D facility
AdvaMed SmartBrief | Feb 17, 2012
Medical device maker Covidien has opened its first research and development facility in India, part of its strategy to tap into emerging markets. The company, which initially has about 30 people working at the new 40,000-square-foot space, plans to add more than 350 employees in the next couple of years. Hindu Business Line (India), The (02/16)
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