FDAnews Device Daily Bulletin

Devicemakers will have an opportunity to air their concerns about the FDA’s postmarket surveillance system at a Monday public meeting in Greenbelt, Md.

The EU last month published its much-anticipated regulation on medical devices and active implantable devices that use tissues of animal origin, but any impact on devicemakers is expected to be minimal, experts say.

A new program to help medical device manufacturers in the Buffalo Niagara region sell their products in China got a boost Thursday from nearly $700,000 in federal and local funding aimed at helping those companies clear export-related hurdles.

Back in June when the House of Representatives voted to repeal the medical device tax that the industry believes will kill jobs and stifle innovation, Rep. Erik Paulsen (R-Minn.) likely believed that he might achieve the impossible: throw out that portion of the healthcare law completely.

A new medical device could alert people that they are about to have a heart attack, even if they are not experiencing any symptoms.

This week's launch of an Australian-first blood glucose meter that hooks straight into an iPhone to record and manage a person's diabetes is the latest in a series of innovations linking specialist medical devices with everyday technology.

Global device company aap Implantate  received 510(k) clearance from the FDA for its LOQTEQ trauma plating system.

Innovative Trauma Care, a Canada-based early-stage medical device firm focused on developing point-of-injury solutions for trauma, first responder and military medicine applications, is making its U.S. headquarters in San Antonio, Texas.