FDAnews Device Daily Bulletin

Reforms in the FDA’s 510(k) procedures are needed to encourage risk-taking and speed the pace at which “substantially equivalent” devices are cleared for marketing, an industry expert says.

Known for its relatively relaxed regulations on companion diagnostics (CDx), guidance from the European Medicines Agency is not expected until there is more experience with these drug-device products, an expert says.

Reviewing the results of a recently completed end-user study, it is clear that social technologies have made some inroads into the medical devices industry, as they have in the greater healthcare industry in general — but there is still a ways to go.

What if you could shut down several emergency rooms simultaneously without leaving your own home?

A transdermal patch delivering rivastigmine (Exelon) at a 40 percent higher rate than the previous maximum strength has been cleared by the FDA for patients with mild to moderate Alzheimer's disease, its manufacturer said.

Pricking a finger every day is just part of everyday life for many diabetes patients.

A Massachusetts jury handed Hologic a $4 million setback in a patent infringement battle with Smith & Nephew over Hologic’s MyoSure fibroid surgery device.

Those with medical device sales jobs may soon be working extra hours as New York-based AngioDynamics gets ready to launch its newest product, the BioFlo peripherally inserted central catheter (PICC) system with Endexo technology, which was recently cleared for market use by the Food and Drug Administration.