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.

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. 

Safety concerns with certain Boston Scientific leads have resulted in multiple Class I recalls, the FDA has announced. The agency first shared a warning about this issue in August. 

The FDA has categorized this as a Class I recall. If patients update their phone or watch apps as needed, they can continue to use these devices like normal.

The veteran interventional cardiologist claims he was pushed out after repeatedly asking for more coverage from cardiothoracic surgeons in addition to other improvements. The hospital, meanwhile, described the lawsuit as a “collection of false allegations."