FDAnews Device Daily Bulletin

The House Wednesday overwhelmingly approved reauthorizing the Medical Device User Fee Act (MDUFA), sending it on to the Senate with a voice vote.

China is expected to begin amending its current medical device rules this year, as part of its 12th five-year plan to update its drug and device regulations, according to a panel of China experts at the Food and Drug Law Institute’s annual conference in Washington, D.C.

Federal regulators today issued two final rules formalizing the FDA review process for new and existing implantable pacemakers and pacemaker programmers.

The DENV-1-4 Real Time RT PCR Assay, developed by the U.S. Centers for Disease Control and Prevention, was recently authorized for use by the FDA.

Medtronic announced that a stent graft to treat thoracic aortic aneurysms is one of nine devices part of a pilot program at the FDA aimed to help establish clinical and safety profiles for novel devices.

Teleflex said it has acquired Cambridge biomedical company Semprus BioSciences, which was spun out from the Massachusetts Institute of Technology.

Greatbatch Medical officially opened its 80,000 square foot orthopaedic manufacturing center in Fort Wayne, Ind.

Using a combination of 160 high-resolution tungsten leaves and dramatically faster leaf movement, Elekta’s revolutionary new Agility MLC promises a new level of precision and delivery speed in radiation therapy treatments for cancer patients.