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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Contego Medical, a North Carolina-based medical device company, has received U.S. Food and Drug Administration (FDA) approval for its new all-in-one carotid stenting offering, the Neuroguard IEP System

FDA gives green light to 3-in-1 carotid stent system designed to limit strokes

The newly approved system includes a stent, dilation balloon and integrated embolic protection filter. After CMS expanded Medicare coverage for carotid artery stenting in 2023, the procedures are expected to grow more and more common as time goes on. 

The iCardio.ai EchoMeasure AI software to automate measurements for cardiac echo imaging. It was FDA cleared in October 2024.

FDA approves AI startup’s new software for echo assessments

iCardio.ai, co-founded by a cardiologist, is part of the Cedars-Sinai Accelerator program. The startup has already announced new partnerships with Viz.ai, Abbott and others in the cardiac health space. 

Example of an automated artificial intelligence (AI) assessment of soft coronary plaque from a CT scan from the vendor Cleerly. The AI gives a very detailed report of all the plaque in all the coronary vessels. Some cardiology experts believe this may be the way of the future in screening patients for early coronary disease and monitoring the impact of prevention efforts such as statins to determine if more aggressive treatments are needed.

Medicare administrative contractors approve coverage of AI-enabled quantitative CT

Four of the seven Medicare Administrative Contractors (MACs) announced they will now cover artificial intelligence-enabled quantitative coronary tomography (AI-QCT) and coronary plaque analysis (AI-CPA). 

HeartFlow Plaque Analysis

CMS updates Medicare coverage for AI-powered coronary plaque assessments

The new policy goes into effect in November, improving Medicare coverage for a technology that has rapidly gained momentum in recent years.

pharmaceutical drug approval process

FDA’s tirzepatide decision creates uncertainty for patients—and leads to a lawsuit

When drugs are on the FDA’s shortage list, outsourcing facilities can produce their own compounded versions. When the FDA removed tirzepatide from that list with no warning, it created a considerable amount of chaos both behind the scenes and in pharmacies all over the country. 

artificial intelligence in cardiology

FDA grants AI-powered ECG screening tool for aortic stenosis its breakthrough device designation

The FDA clearly sees significant potential in this new screening software from New York-based AccurKardia.

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Vaping with e-cigarettes linked to multiple cardiovascular risks

This study adds to growing evidence that e-cigarettes play a significant role in cardiovascular problems, similar to smoking. Researchers hope their work can help lead to new public health policies. 

An FDA panel will discuss its recommendations related to Abbott's TriClip G4 transcatheter edge-to-edge repair (TEER) system for tricuspid regurgitation.

CMS considers Medicare coverage options for tricuspid valve repair at Abbott’s request

CMS is now accepting public comments on this topic until Nov. 2. A final decision is expected by July 2025.

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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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