Devices & Diagnostics Letter

A 16-month Senate Finance Committee investigation of Medtronic revealed dubious ties with researchers and behind-the-scenes efforts to ensure medical journals portrayed the company’s InFuse bone graft favorably, according to a report released Wednesday.

The FDA’s Radiological Devices Advisory Panel voted Wednesday to support expanded indications for the Hologic Selenia Dimensions C-View Software Module when used with the Selenia 3-D mammography device.

St. Jude Medical announced Thursday that the company’s Amplatzer PFO Occluder has missed its primary endpoint in the RESPECT trial to evaluate the device’s success at reducing recurrent stroke risk.

Edwards Lifesciences garnered FDA approval of an expanded indication for the Sapien heart valve Oct. 19, just ahead of the company’s announcement of 9 percent sales growth in the 2012 third quarter.

The medical device industry remains largely unprepared for the risk posed to technology by malware and computer viruses, one computer security expert says.

Warning letters to two distributors of unapproved devices highlight ongoing FDA efforts to crack down on illegal internet sales and promotions.

Medical device spending in the U.S. has grown at a constant rate of less than 1 percent a year since 1989, and prices for devices have increased about 1 percent annually over the past two decades, according to a new industry-funded report.

A New Jersey District Court judge has given Wright Medical an extra two weeks to respond to a Stryker lawsuit alleging the orthopedics company infringed Stryker’s GETAROUNDKNEE trademark.