FDAnews Device Daily Bulletin

Devicemakers can begin taking steps to comply with new electronic copy requirements for most types of FDA submissions, thanks to an FDA draft guidance.

In response to the rapid rise in counterfeits, the International Organization for Standardization (ISO) has issued a new industrywide standard to help ensure the life-cycle integrity of products.

Stentmaker Stentys won FDA investigational device exemption to launch its first U.S. clinical trial of its Self-Apposing stent that it hopes to use in support of a premarketing approval bid.

A surgical device developed by two Wilmington medical professionals is slated for market launch in early November.

Cappella Medical Devices, a medical device company developing dynamic solutions for the treatment of coronary bifurcation disease, announced the multicenter long-term follow-up results for its innovative Sideguard coronary sidebranch stent.

A federal judge who has already made a preliminary finding that Stryker is likely to prevail on its claim that a Wright Medical Technology website infringes on the former’s “GETAROUNDKNEE” trademark has been asked to extend Wright’s deadline to answer until Nov. 2.

A Delaware federal jury found last week that medical devicemaker Volcano had not violated four St. Jude Medical patents that cover a family of pressure guide wire products used by cardiologists.

Kona Medical announced the initiation of the first clinical study of its device therapy for drug-resistant hypertension.