Policy & Regulations

This channel includes news coverage of healthcare policy and regulations set by Congress, the states, Centers for Disease Control and Prevention (CDC), the Department of Health and Human Services (HHS), U.S. Food and Drug Administration (FDA), and medical associations and societies. 

Most devices implanted during LAAO procedures are oversized—and patients benefit

Oversized devices are becoming more common as time goes on, which suggests operators are growing increasingly comfortable with this treatment choice.

FDA changes indications for Impella RP heart pump after dramatic shift in mortality rate

The Impella RP System is still associated with significant benefits, the FDA said, but there are certain high-risk patients who should no longer be eligible for treatment.

Sphere-9 mapping and ablation catheter

Medtronic reaches milestone in study of pulsed-field ablation and mapping catheter for AFib

A randomized study of more than 450 patients with persistent atrial fibrillation is now underway. All patients have been treated, and their outcomes will be tracked for 12 months. 

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FDA announces another recall for troubled heart device after multiple hospitalizations

This latest recall involves the device's driveline boot cover, which “can become stiff over time” and cause problems for clinicians. There have been 33 complaints since 2017 related to the issue.

High copays keep many heart failure patients from filling needed prescriptions

Researchers examined data from more than 900 patients, presenting their findings in the Journal of the American Heart Association.

doctor fruits vegetables vegetarian diet

Cardiologist urges physicians to promote plant-based diets: ‘We owe it to the profession, our patients and the planet’

The authors of a new commentary in the American Journal of Cardiology argued that well-balanced plant-based diets are good for the heart and good for society as a whole. 

Anteris Technologies duravr heart valve

Regulatory Roundup: Updates on Medtronic and LivaNova recalls, FDA-cleared AI models, a new heart valve and more

Read our recap of some of the biggest FDA-related stories that impacted cardiology in the last month.

cardiology virtual reality osso vr

American College of Cardiology announces new collaboration with virtual reality specialists

The ACC is especially excited to see what VR training can do to bring minimally invasive interventional procedures to more and more patients throughout the United States.

Around the web

Ron Blankstein, MD, professor of radiology, Harvard Medical School, explains the use of artificial intelligence to detect heart disease in non-cardiac CT exams.

Eleven medical societies have signed on to a consensus statement aimed at standardizing imaging for suspected cardiovascular infections.

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