FDAnews Device Daily Bulletin

The FDA is considering the creation of a new Division of International Compliance Operations within CDRH’s Office of Compliance (OC) as part of the center’s efficiency drive and the agency’s increased international focus, CDRH officials say.

The device industry remains largely unprepared for the risk posed to technology by malware and computer viruses, one computer security expert says.

As the comment period closes on long-awaited regulations to implement an identification system for most medical devices, some providers are voicing concerns.

Your own beating heart may generate enough electricity to power a heart-regulating pacemaker, ending the need for expensive surgeries to replace expiring batteries, according to an early study of an experimental energy-converting device.

Today’s intensive care units bear little resemblance to their late-20th-century counterparts.

A Michigan federal judge on Thursday rejected Stryker’s renewed bid to halt the sales activity of a former high-ranking employee who jumped ship to rival medical devicemaker Zimmer and allegedly attempted to lure customers away with Stryker’s proprietary pricing strategies.

The majority of prostheses available today that replace the lower leg, ankle and foot are passive devices that store energy in an elastic element (similar to a coiled spring) at the beginning of a step and release during push-off to give you some added boost.

A survey of 31 San Francisco venture capitalists’ outlook for the next six to 18 months has found confidence up slightly in the third quarter of the year, but not for life science and healthcare investing where the landscape will get more challenging before it improves.