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Fdanewsdevicedailybulletin

Feb. 7, 2012

Vol. 9 No. 26

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AdvaMed: MDUFA Agreement Could Be ‘Game Changer’ for FDA, Industry

A compromise reached by the FDA and device industry on medical device user fee reauthorization should benefit both parties and speed patient access to innovative technologies, AdvaMed President Stephen Ubl said. Read More

EU Reg Would Ban Mercury in Sphygmomanometers

Citing the availability of safer alternatives, the European Commission is proposing a near-total ban on mercury measuring devices, beginning Aug. 1. Read More

China Department of Health Issues Stent System Device Alert

Cordis stent defect leads to a field safety notice for its S.M.A.R.T. Control Nitinol stent system due to a potential sterility breach in the pouches of all unexpired lots. Read More

Baucus to Explore Ways to Increase Price Transparency in Medical Device Industry After New Report Reveals Gaps

Senate Finance Committee Chairman Max Baucus (D-Mont.) pushed for increased transparency in the medical device industry in order to guarantee hospital, Medicare and taxpayers are paying fair value for the implanted devices used in hospital care. Read More

Med Tech Tax: IRS Releases Guidance on 2.3 Percent Levy, Paulsen Calls for a Vote on Repeal

The U.S. Department of the Treasury released proposed regulations on who will and who won’t be subject to the 2.3 percent medical device tax, carving out some exemptions for early-stage devices and providing a little clarity on fears of a double tax for contract manufacturers, importers and component manufacturers. Read More

New, Disposable Catheter Design Ready for Launch

As he showed off Swan Valley Medical’s new catheter insertion device last month, Larry Sampson pointed out a painful truth about the catheter business. Read More

Solitaire Clot Retrieval Device Outperforms Merci in Stroke

Acute cerebral ischemia was more successfully treated with a new stent retriever, the Solitaire Flow Restoration device, than with the FDA–approved Merci Retrieval System. Read More

Man Uses USB Device, Program to Store Vital Medical Information

When John Decker’s wife, Karen, was transported to the Aiken emergency room about a year ago, doctors relied on Decker to provide medical information that his wife was unable to provide for herself. Read More

Next-Generation Stent Manufacturing

Predicting the future of coronary artery disease treatment is not for the faint of heart. Read More