FDAnews Device Daily Bulletin

Questions announced this month for a November meeting on the future of Medicare coverage for ventricular assist devices (VAD) appear to give devicemakers little to worry about, one analyst says.

An FDA inspector’s determination that a single product at Dynatronics’ Ooltewah, Tenn., manufacturing plant fit Class II requirements triggered a 15-count Form 483 at the conclusion of a May 21-23 inspection, company President Kelwyn Cullimore Jr., told GMP.

As consumers we want our electronic gadgets to be durable. But as patients, we might want them to dissolve — inside our bodies.

Wireless medical devices are potentially vulnerable to being remotely controlled by hackers and should be tracked more closely, according to a Government Accountability Office report.

Global competition and the impending medical device tax, set to begin Jan. 1, 2013, are creating challenges for the U.S. biomedical device industry, according to a new study by tax advisory firm WTP Advisors.

Medtronic agreed to pay $816 million for orthopedic implant maker China Kanghui, gaining a broader foothold in the nation’s device market with its biggest overseas acquisition.

Codman & Shurtleff, a developer of several medical devices including catheters, trauma monitoring devices, drug pumps and surgical instruments, has seen positive results of its vascular reconstruction device, a self-expanding stent used in patients with wide neck sacular aneurysms.

Salt Lake City, Utah-based Amedica announced it has received regulatory clearance for the second generation of an interbody fusion device system.