The balloon-free catheter, which already had a successful launch in the United States, has been associated with positive outcomes and the ability to reach certain lesions more accurately than balloon-based IVL platforms.

Heart teams continue to play a major role at hospitals and health systems all over the world. Cardiac imagers who have trained in multiple modalities can provide those teams with a significant amount of value.

The FDA’s decision arrived just days after Apple announced the new feature. "This tool empowers patients and clinicians to work together, putting prevention at the center of care," one cardiologist told Cardiovascular Business.