Devices & Diagnostics Letter

In a move that could cost devicemakers millions of dollars, an FDA advisory panel has backed the agency’s proposal to classify automated external defibrillators (AEDs) as Class III devices that must go through the PMA process.

Device industry and standards experts are scratching their heads over claims made by CDRH Director Jeffrey Shuren that the EU allows more unsafe devices on the market than the U.S.

The device industry welcomed President Barack Obama’s calls to further innovation in his State of the Union address last week.

Several devicemakers ended 2010 on a low note with quarterly sales and profits slipping, but at least one company bucked the trend, reporting an increase.

Manufacturers of implantable cardioverter defibrillators (ICDs) may see up to a 10 percent loss in business in the near future in light of an ongoing Justice Department investigation, which is now being supported by the Heart Rhythm Society (HRS).

Manufacturers of breast implants will have to update their labeling to warn of a possible link between the devices and a rare form of non-Hodgkin’s lymphoma.

An FDA advisory panel has backed expanding the indication for Abbott Laboratories’ RX Acculink Carotid Stent System to include use in lower-risk carotid endarterectomy patients.

Failure to notify the FDA of field corrections and complaint-handling issues have resulted in a warning letter to Tosoh Biosciences.

A long-standing warning letter that has held up FDA approval of a few Medtronic cardiac devices may be closed soon.

Developers of devices to address unmet pediatric needs may qualify for a piece of a $2.5 million FDA grant.

An FDA advisory committee said an Eli Lilly contrast agent that may be useful in predicting Alzheimer’s disease could be approved if the company conducts physician training to make sure brain scans are read consistently.

Boston Scientific and its subsidiary, Guidant, are facing a new lawsuit relating to Guidant’s handling of defective implantable cardioverter defibrillators (ICDs) earlier this decade.

Devicemakers on both sides of the Atlantic are urging restraint as the European Commission (EC) proposes another round of changes to the EU’s Medical Device Directives (MDD).