FDA’s New Global Cardiovascular Registry to Start with Transcatheter Heart Valves

The FDA announces a public meeting to discuss international cooperation in monitoring and assessing cardiovascular medical devices, with an initial pilot phase to focus on transcatheter heart valves.

The FDA plans to launch a global cardiovascular medical device registry, with initial efforts to focus on coordinated efforts to monitor transcatheter heart valve technology.

The federal watchdog agency will host a public meeting later this month to discuss goals and strategies for organizing such an effort, which the FDA is calling the “International Consortium of Cardiovascular Registries.”