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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Medicare coverage expands again for AI-enabled coronary plaque assessments

Another MAC has agreed to cover the use of these advanced technologies to evaluate patients for signs of coronary artery disease. 

Boston Scientific Obsidio instructions updated

4 deaths prompt updated instructions for embolic agent used in IR procedures

The Obsidio Conformable Embolic is routinely used for vascular embolization procedures.

FDA announces recall of Boston Scientific's Obsidio Conformable Embolic

Boston Scientific updates instructions for recalled embolic agent linked to multiple deaths

The premixed embolic agent is designed to embolize hypervascular tumors and occlude blood flow in a patient's peripheral blood vessels. It was recalled in April due to safety concerns.

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. 

ai in healthcare

AI software that boosts detection of small brain lesions gains FDA clearance

The software is a collaboration between Bracco Diagnostics, a subsidiary of Bracco Imaging, and Subtle Medical, Inc.

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). 

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Many radiology PowerPoints inadvertently put private health information at risk

Many of these files are still readily available online, and numerous contain PHI that is “easily accessible,” a new analysis reveals.

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Around the web

Cardiovascular Business
Global shortage of nuclear imaging isotopes may be over

The nuclear imaging isotope shortage of molybdenum-99 may be over now that the sidelined reactor is restarting. ASNC's president says PET and new SPECT technologies helped cardiac imaging labs better weather the storm.

Cardiovascular Business
‘A huge win’: CMS significantly increases Medicare payments for cardiac CT

CMS has more than doubled the CCTA payment rate from $175 to $357.13. The move, expected to have a significant impact on the utilization of cardiac CT, received immediate praise from imaging specialists.

Cardiovascular Business
FDA clears AI tool that flags signs of heart disease in chest CT scans

The newly cleared offering, AutoChamber, was designed with opportunistic screening in mind. It can evaluate many different kinds of CT images, including those originally gathered to screen patients for lung cancer. 

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