FDAnews Device Daily Bulletin

The fiscal 2013 medical device user fee rates laid out in a Federal Register notice match amounts set during MDUFA negotiations between the agency and industry representatives.

European medical devicemakers will be required to use a new labeling standard that reduces the need for multiple languages on a single label and reduces potential confusion and delays for selecting the appropriate language when using a device.

Stryker Corp.’s Wingspan brain stent will be limited to use by a smaller group of patients than U.S. regulators initially approved and the device will now require post-market monitoring, U.S. regulators said.

Cytori Therapeutics has expanded the Celution System CE Mark in Europe to include several new indications, including cryptoglandular fistula.

A wrist watch-like device developed by Cory Cornelius, a scientist at Dartmouth University, can determine a person’s “bioimpedance” that would enable a medical device to identify its wearer.

A tiny heart pump that maintains blood flow in babies and small children with serious heart failure proved effective and life-saving in a pioneering study involving 17 institutions led by Texas Children’s Hospital and Baylor College of Medicine (BCM).

The University of Minnesota’s Medical Devices Center has filed 109 invention disclosures since it was established in spring 2008.

The first patient injury lawsuits following the high-profile recall of Johnson & Johnson subsidiary DePuy Orthopaedics’ metal-on-metal hip implants are set to begin next year.