Devices & Diagnostics Letter

Due to summer holidays, Devices & Diagnostics Letter will not be published July 9. The next issue will be published July 16.

Industry vowed to redouble its fight for repeal of the medical device tax in the wake of the U.S. Supreme Court’s 5-4 vote upholding President Barack Obama’s healthcare reform law.

Two days of public debate over the safety of metal-on-metal (MoM) implantable hip prostheses raised a host of questions, but few answers.

A letter from device and diagnostic company Cook Group appears to be behind the FDA’s decision to withdraw a final rule on transparency of agency memoranda of understanding (MOUs).

Device groups praised the Senate’s Tuesday afternoon passage of legislation reauthorizing the Medical Device User Fee Act (MDUFA) for another five years.

The FDA is taking a hard look at requirements for clinical trials of hospital blood glucose sensors in hopes of speeding their availability in the U.S. over the next several years, agency officials said during a June 25 public hearing on the devices.

Covidien’s January recall of a surgical staple product hasn’t ended the company’s troubles, as an FDA warning letter questioning Covidien’s handling of safety concerns makes clear.

Compared with the EU and other international markets, medical devicemakers face greater regulatory uncertainty and a more burdensome approval process for their products in the U.S., an industry survey concludes.

The House has passed H.R. 4223, the SAFE Doses Act, by voice vote, taking another step toward ramped-up penalties for medical product thefts.

After 12 years, the Global Diagnostic Imaging, Healthcare IT & Radiation Therapy Trade Association (DITTA) has officially incorporated in the U.S., a move that will allow it to better influence discussions on global medical imaging concerns, an association official says.