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. 

the words "FDA recall" on a board

FDA announces new recall of Johnson & Johnson heart pumps over safety concerns

No devices need to be returned at this time. However, the FDA warned, using these heart pumps without reviewing the updated instructions could result in "serious injury or death.” 

Heart cardiologists doctors surgery

Cardiologists recommend AVR for asymptomatic severe AS—TAVR and surgery both viable options

A trio of leading voices in cardiology reviewed years of data while considering their proposal. The choice between TAVR and SAVR, they added, should be made on a case-by-case basis.

ACC Vice President Christopher Kramer, MD, FACC, offers an update on the creation of a new cardiovascular board.

Final decision on the creation of a new cardiovascular board expected soon

U.S. cardiology groups have worked together to propose the creation of a new American Board of Cardiovascular Medicine for certifying cardiologists. Now, after many months of waiting, a final decision is expected by the end of February. 

The impact of Trump tariffs on iodine contrast media costs

GE HealthCare said the price of iodine contrast increased by more than 200% between 2017 to 2023. Will new Chinese tariffs drive costs even higher?

ACC President Cathie Biga explains the American College of Cardiology advocacy efforts in Washington D.C. in 2025.

ACC president details key advocacy efforts in cardiology

American College of Cardiology President Cathie Biga, MSN, says Medicare payment reform remains a top priority going forward. Site-neutral payments and improved access to PAD screening are two other issues close to the ACC's heart. 

heart surgery cardiac surgeons

Benzodiazepine use before heart surgery: Should it be embraced or restricted?

Benzodiazepines are administered before a majority of cardiac surgeries to lower the risk of intraoperative awareness. At the same time, however, recent studies have suggested they increase the risk of postoperative delirium.

The U.S. Food and Drug Administration (FDA) has shared a new warning about ongoing safety issues with atherectomy devices sold and distributed by Bard Peripheral Vascular, an Arizona-based subsidiary of Becton, Dickinson and Company (BD). The warning includes multiple models of Bard Peripheral Vascular’s Rotarex Atherectomy System, which is designed to target high-risk plaques and blood clots in the peripheral arteries by rotating at a high speed.

FDA warns that atherectomy devices are breaking during use—30 serious injuries, 4 deaths reported

More than 100 incidents have been reported so far. The FDA is still evaluating this issue, but the agency wanted to raise awareness as quickly as possible.

FDA warns that smartphone-compatible diabetes devices may not work properly

Smartphones have made it easier than ever for patients to monitor their own health, but the technology is far from infallible. 

Around the web

GE HealthCare said the price of iodine contrast increased by more than 200% between 2017 to 2023. Will new Chinese tariffs drive costs even higher?

Several key trends were evident at the Radiological Society of North America 2024 meeting, including new CT and MR technology and evolving adoption of artificial intelligence.