The FDA shared a warning about these safety issues in February, but said it was still reviewing the evidence. The agency is now saying the devices “may cause serious injury or death” if used without following the updated instructions for use.

The drug in question, ataciguat, could help heart patients avoid aortic valve replacement—or at least put it off until later in life.

CMS will cover TTVR for the treatment of symptomatic tricuspid regurgitation on a national level. The agency first proposed such a policy in December, taking time to consider public comments before finalizing its decision.

The country’s two biggest TAVR vendors both plan on making a splash at ACC.25. Medtronic and Edwards Lifesciences spoke to Cardiovascular Business about their plans for the three-day event in Chicago.

The American College of Cardiology has sent a letter to HHS Secretary Robert F. Kennedy Jr. that outlines some of the organization’s central priorities and concerns. 

As coronary CT angiography (CCTA) continues its rapid expansion, scanner vendors are now offering more economical solutions to ensure access to imaging technology beyond premium systems most often only found at flagship hospitals and academic centers. To conquer CCTA’s technical challenges, new technologies and AI are being incorporated into a new scanner to simplify acquisition and consistently improve image quality. 

Abbott has received an investigational device exemption from the FDA for a new clinical trial evaluating the safety and effectiveness of using its coronary IVL technology. The trial is expected to enroll up to 335 U.S. patients.

Researchers focused on a relatively young patient population, hoping to learn as much as possible about the surgical valve's safety and effectiveness over an extended period of time. 

Laxmi Mehta, MD, detailed several ways she and her colleagues at The Ohio State University are working to combat the rising levels of burnout among cardiologists.

Powerful Medical's advanced algorithm was designed to detect STEMI and STEMI-equivalent patterns in a patient’s ECG results.