FDAnews Device Daily Bulletin

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.

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

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.

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.

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.

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.

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.

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.

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