FDAnews Device Daily Bulletin

Trial sponsors should notify the FDA about all adverse events brought to their attention by data monitoring committees (DMC), regardless of whether the safety issue is “serious” or not, according to an agency guidance.

A Dutch proposal to tighten device vigilance in the EU would intensify inspections of devicemakers that operate internationally and organize surveillance around the complete life cycle of specific product lines.

Dr Arabin GmbH & Co. has issued a field safety notice for its Cerclage Pessaries Type ASQ.

Johnson & Johnson Ethicon Endo-Surgery won FDA clearance for the first surgical instruments that can be assembled and disassembled inside the body during surgery.

Where have all our medical device companies gone? Starting with Medtronic’s introduction of the implantable pacemaker in the 1960s, a cluster of publicly held medical device companies has grown up in Minnesota resulting in the highest per-capita medical device employment of any state.

Great Basin today announced it has received 510(k) clearance from the FDA for its first molecular diagnostic test for Clostridium difficile.

Johnson & Johnson said it has acquired a China-based devicemaker to broaden its business in China and expand a collection of products designed to control surgical bleeding.

Medtronic plans to cut 220 employees in its Cardiac Rhythm Disease Management division across the United States.

Theragenics announced that Galt Medical launched its Microslide Pediatric Introducer line featuring tearaway sheath introducers, small diameter guidewires and short needles.