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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HeartFlow Plaque Analysis Example

New Category I CPT code issued for AI-enabled coronary plaque analysis software

The news comes just days after CMS confirmed these technologies would start receiving expanded Medicare coverage in November. HeartFlow and other AI vendors have already shared their excitement over the decision. 

Advanced device-based therapies are associated with significant benefits for heart failure patients and should be used alongside traditional pharmaceutical treatments, according to a new scientific statement from the Heart Failure Society of America (HFSA). The statement, published in full in the Journal of Cardiac Failure, examines a number of new-look medical devices that have emerged in recent years as additional ways to treat heart failure.

Cardiologists make case for increasing use of device-based therapies for heart failure

Device-based therapies can provide considerable value for heart failure patients when used alongside traditional pharmaceutical treatments. A new HFSA scientific statement outlines the benefits of these devices, urging care teams to implement them into daily practice. 

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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Around the web

Radiology Business
Key takeaways from RSNA 2024 for AI, CT, MRI and the radiology staffing shortage

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.

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.