FDAnews Device Daily Bulletin

The FDA last week released updated guidance describing how it intends to comply with submission review timelines set during user fee negotiations earlier this year.

The Saudi Food and Drug Authority has rejected millions of dollars in medical device imports over the past three years, in an effort to prevent substandard products entering the country, an SFDA official says.

According to a recent report by the Government Accountability Office (GAO), there’s a growing danger that grandpa’s heart rhythm device, or, say, a child’s insulin pump — any implantable device that can be accessed remotely — could be susceptible to hacking.

St. Jude Medical’s pacemaker-like device gives some relief to those with chronic pain.

In a new campaign advertisement, Republican congressional candidate Jackie Walorski talks about “a hidden tax on medical devices” in the 2010 Affordable Care Act.

Morton Plant Hospital is the first hospital in the Tampa, Fla., area to perform Transcatheter Aortic Valve Replacement (TAVR) by the transapical approach.

W.L. Gore & Associates recently urged the U.S. Supreme Court to overturn an appeals court ruling that heightened the standard for proving willful infringement, saying the revamped benchmarks would have a chilling effect on valuable research.

Cappella Medical Devices announced the multicenter long term follow up results for its Sideguard coronary sidebranch stent.