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Most Clicked AdvaMed SmartBrief Stories


1. Hamburg says FDA working to address problems at device unit

AdvaMed SmartBrief | Nov 13, 2009

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)


2. Stryker CEO discusses firm's approach to acquisitions

AdvaMed SmartBrief | Nov 17, 2009

Stryker's efforts to resolve issues that were found by the FDA at some of its manufacturing plants and discussions over its marketing practices have slowed the pace of the company in terms of spending on acquisitions, CEO Stephen P. MacMillan said. MacMillan said the company is also cautious on spending because some potential target firms are overvalued due to sales and marketing practices that don't agree with Stryker's practices. Wall Street Journal, The (11/16)


3. FDA sends Medtronic a warning letter over issues at Minn. facility

AdvaMed SmartBrief | Nov 19, 2009

The FDA has issued a warning letter to Medtronic asking the firm to take corrective actions and evaluate its field action recommendations, among other requests, following an inspection of its facility in Mounds View, Minn., where the company has its cardiac rhythm management headquarters. Medtronic said it will answer the notice within 15 days and that it has started addressing the issues raised by the agency. Reuters (11/18)


4. Medtronic to unveil distribution center in Tennessee

AdvaMed SmartBrief | Nov 17, 2009

Medtronic is set to open today in Memphis, Tenn., a center that will distribute its spinal implants, pacemakers and other products. The $65 million distribution facility is expected to hire more than 260 workers. American City Business Journals (11/17)


5. Edwards CEO: Devices to face pricing pressure from hospitals

AdvaMed SmartBrief | Nov 13, 2009

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)


6. Massachusetts trade group opposes tax on device firms

AdvaMed SmartBrief | Nov 16, 2009

The Massachusetts Medical Device Industry Council has expressed opposition to House and Senate bills that include a proposal to tax device makers to help pay for health reform and wants an amendment that would lift the tax from the Senate measure, said Thomas J. Sommer, the trade group's president. "We would prefer that there not be a tax ... we're hoping it will be closer to $20 billion," said AdvaMed Senior Executive Vice President David Nexon. Boston Globe, The (11/13)


7. TriVascular to expand Calif. operations with $30M cash infusion

AdvaMed SmartBrief | Nov 17, 2009

Startup firm TriVascular has raised $30 million from New Enterprise Associates and other investors. The company will use the proceeds to broaden its operations in Santa Rosa, Calif., as it prepares to perform clinical studies of its stent grafts designed to treat patients with aortic aneurysms. Press Democrat (Santa Rosa, Calif.), The (11/16)


8. Medtronic unveils diabetes center in San Antonio

AdvaMed SmartBrief | Nov 18, 2009

Medtronic has opened a center in San Antonio that will offer patients and clinicians customer service and education on the use of its insulin pumps and other devices used for managing diabetes. The Diabetes Therapy Management and Education Center currently has 200 workers and is expected to recruit nearly 1,400 employees in the next five years. American City Business Journals (11/17)


9. Senate's health care bill would reduce deficit by $130B

AdvaMed SmartBrief | Nov 19, 2009

The Congressional Budget Office said the Senate's health care bill would reduce the U.S. budget deficit by about $130 billion in its first 10 years. The measure presented by Senate Majority Leader Harry Reid, D-Nev., would extend coverage to 31 million Americans but would also delay the rollout of the new program to 2014. The first test of the measure's fate in the Senate will come in a procedural vote expected on Friday or Saturday, when Reid will need 60 votes to overcome Republican opposition and begin debate. New York Times, The (11/18) Washington Post, The (11/19) Wall Street Journal, The (11/19)


10. Health reform could boost mergers in device sector, J&J exec says

AdvaMed SmartBrief | Nov 13, 2009

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. Wall Street Journal, The (11/12)




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