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. 

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Abbott has gained U.S. Food and Drug Administration (FDA) approval for its Navitor transcatheter aortic valve replacement (TAVR) system, the company’s new self-expanding valve for high-risk patients with severe symptomatic aortic stenosis.

Abbott receives FDA approval for new self-expanding TAVR system

The device, which gained CE mark approval in Europe in May 2021, features a new-look fabric cuff designed to keep the risk of paravalvular leak (PVL) at a minimum.

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Medicare update designed to help heart failure patients may have the opposite effect

When Medicare made it easier for heart failure patients to receive a LVAD at a hospital that does not perform heart transplants, the change was intended to improve patient access. It turns out, however, that the policy shift could be linked to an unintended consequence. 

cardiologist doctor physician patient black diverse hypertension

Cardiologists push for a more diverse, inclusive healthcare workforce

A recent roundtable discussion focused on how today's healthcare leaders can "begin to dismantle the systems that perpetuate inequities in medicine and build new systems that promote diversity, equity and inclusive excellence."

The Dexcom G7 Continuous Glucose Monitoring System

Regulatory Roundup: FDA news on omecamtiv mecarbil for HFrEF, 'world's smallest heart pump' and more

Read our monthly recap of some of the biggest FDA-related stories that have hit cardiology, including updates related to Cytokinetics, Dexcom and Abiomed. 

FDA announces recall of intra-aortic balloon pumps due to risk of cardiac arrest, stroke or death

The recall includes more than 2,000 devices distributed to customers in 2022. There have been 241 complaints, and 135 reported pump stops, related to this issue. 

How cardiologists can fight back against misinformation

Edward T.A. Fry, MD, president of the American College of Cardiology and a veteran cardiologist, shared his perspective on the many ways cardiologists can work to limit medical misinformation and disinformation. 

FDA adds diabetes medicine to drug shortage list

A diabetes treatment drug, Mounjaro, has been added to the Food and Drug Administration’s (FDA) list of drug shortages.

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World’s leading cardiology groups say it is time to rethink RCTs

The American College of Cardiology, American Heart Association, European Society of Cardiology and World Heart Federation all collaborated on a joint statement aimed at updating the rules and regulations associated with randomized clinical trials

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Around the web

Health Imaging
Use of AI opportunistic screening in CT for cardiovascular disease

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

Health Imaging
New imaging protocols proposed to curb rise of cardiovascular infections

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