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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Expanding Medicaid linked to better care for heart patients

New research, based on data from approximately 143 million patients, focused on prescriptions for heart failure, atrial fibrillation and other significant cardiac conditions. 

GE Healthcare recall TruSignal SpO2 sensors

GE Healthcare recalls certain SpO2 sensors due to risk of serious errors during defibrillation

There is a risk of the devices sending a reduced amount of energy to the heart during defibrillation. More than 7,000 devices are being recalled due to this issue.

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FDA announces recall of nearly 8,000 Impella blood pumps due to risk of injury or death in TAVR patients

There have been 30 complaints so far about this issue, including 26 injuries and four deaths.

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Abbott recalls delivery sheath for LAA occluder device after 16 injuries

The FDA has categorized this as a Class I recall, which means using the devices “may cause serious injuries or death.”

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New U.S. guidelines on chronic coronary disease rethink use of beta-blockers, other medications

The updated recommendations from the American College of Cardiology and American Heart Association cover a variety of topics, including patient communication, follow-up imaging, nutritional supplements and more. 

FDA provides next steps in wake of blood test recall

According to the FDA, a limited number of unaffected blood tests are available if providers are unable to identify a better way forward. 

Image of a bioprosthetic valve within the RVOT from the SCCT's congenital heart disease guidelines

SCCT shares new recommendations on use of CT imaging to guide congenital heart disease treatment

The group collaborated with two other medical societies, SCAI and CHSS, on the expert consensus document. 

the words "FDA recall" on a board

Medtronic recalls nearly 350,000 implantable heart devices after 22 injuries

The FDA has categorized this as a Class I recall, meaning the use of these devices could cause “serious injuries or death.”

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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.

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