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Vice President of Service and Support Operations at FUJIFILM Medical Systems USA, Inc.

FDA regulators moved quickly to accelerate the delivery of replacement parts for imaging equipment that has proven to be critical tools in the diagnosis and treatment of COVID-19.


How Industry-FDA Cooperation Removed Medical Imaging Device Delivery Delays 

The use of artificial intelligence (AI) tools to provide quantitative coronary tomography (AI-QCT) and coronary plaque analysis (AI-CPA) based on coronary computed tomography angiography (CCTA) will soon be covered by four Medicare administrative contractors (MACs).

Starting on November 24, the MACs Palmetto GBA, National Government Services (NGS), CGS Administrators and WPS administrative groups will cover the use of AI-QCT and AI-CPA for Medicare beneficiaries with acute or stable chest pain, and no known coronary artery disease (CAD), according to a recently updated local coverage determination (LCD) issued by the Centers for Medicare and Medicaid Services (CMS).

The LCD noted coverage of AI tools will be provided for the testing of patients deemed to be at intermediate risk for CAD, or those classified by the Coronary Artery Disease Reporting and Data System (CAD-RADS) as having CAD-RADS 1, CAD-RADS 2 or CAD-RADS 3, based on CCTA findings. The coverage will also apply for those who have had negative or inconclusive evaluation for acute coronary syndrome (ACS), according to the LCD.

The use of the FDA-cleared AI modalities 

“Coronary artery disease is the underlying cause of about 50% of deaths,” noted Ron Blankstein, M.D., the director of cardiac computed tomography at Brigham and Women's Hospital and a professor of medicine at Harvard Medical School in Boston. “Medicare coverage of HeartFlow Plaque Analysis is a major step forward in improving coronary artery disease management. The earlier we can diagnose and use tools to provide accurate plaque quantification, the earlier we can provide tailored treatments, potentially improving outcomes for patients.”

“We are also extremely thankful to the many physicians and medical society partners who used their voices to advocate for this essential AI-QCT technology. Until Cleerly, health-care providers have not had a way to easily and completely assess the primary cause of heart attacks, atherosclerotic plaque burden and type in a non-invasive way, which is especially important for our senior population,” noted James L. Kim, M.D., the CEO and founder of Cleerly. “This decision by the MACs represents a significant step in advancing the field of cardiology and providing the best possible care for our seniors.”

(Editor’s note: For related content, see “

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1. Centers for Medicare and Medicaid Services (CMS). Artificial intelligence enabled CT based quantitative coronary topography (AI-QCT)/coronary plaque analysis (AI-CPA). Available at: 

https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdid=39851&ver=10

 . Published October 10, 2024. Accessed October 14, 2024.

2. Cleerly. Medicare administrative contractors approve coverage of Cleerly heart scans to Medicare recipients. Business Wire. Available at: 

https://www.businesswire.com/news/home/20241014694634/en/Medicare-Administrative-Contractors-Approve-Coverage-of-Cleerly-Heart-Scans-to-Medicare-Recipients

 . Published October 14, 2024. Accessed October 14, 2024.

3. HeartFlow. HeartFlow announces favorable coverage determination for plaque analysis by four Medicare administrative contractors. GlobeNewswire. Available at: 

https://www.globenewswire.com/news-release/2024/10/11/2962144/0/en/HeartFlow-Announces-Favorable-Coverage-Determination-for-Plaque-Analysis-by-Four-Medicare-Administrative-Contractors.html

4. Elucid. Elucid announces favorable Medicare coverage of AI coronary plaque analysis. Business Wire. Available at: 

https://www.businesswire.com/news/home/20241015489543/en/Elucid-Announces-Favorable-Medicare-Coverage-of-AI-Coronary-Plaque-Analysis

 . Published October 15, 2024. Accessed October 15, 2024.

Four Medicare administrative contractors (MACs) will provide coverage of AI-enabled coronary plaque analysis and quantitative coronary tomography assessment of coronary computed tomography angiography (CCTA) for Medicare beneficiaries starting in November 2024.

Topic

Medicare to Cover AI-Powered, CCTA-Based Coronary Plaque Analysis and Quantitative Coronary Topography 

The Food and Drug Administration (FDA) has granted 510(k) clearance for AngioFlow™, an artificial intelligence (AI)-enabled perfusion imaging software that may facilitate more timely assessments of perfusion status prior to endovascular procedures.

Offering color-coded perfusion mapping that identifies regions with reduced cerebral blood flow and blood volume, 

 provides results within minutes of a cone-beam computed tomography (CT) scan, according to RapidAI, the manufacturer of AngioFlow.

In addition to potential cost savings by reducing redundant imaging, RaidAI emphasized that AngioFlow’s timely assessments may reduce long-term disability risks and facilitate life-saving interventions for patients in need of acute stroke care.

“AngioFlow by RapidAI will allow physicians to assess the need for additional imaging immediately in the interventional suite. By avoiding unnecessary scans, stroke patients can receive the timely care that can be the difference between being able to walk out of a hospital to their homes versus being discharged to a skilled nursing facility,” said Abhishek Singh, MD, DABPN, DUCNS, who is affiliated with the Creighton University School of Medicine in Omaha, Nebraska.

The company added that AngioFlow has been validated in more than 10 clinical trials.

Reportedly validated in more than 10 clinical trials, the AngioFlow perfusion imaging software enables timely identification of brain regions with cerebral blood flow reduction and those with significant hypoperfusion.

FDA Clears AI-Powered Qualitative Perfusion Mapping for Cone-Beam CT

A 57-year-old female presents for a screening mammogram. The patient has heterogeneously dense breasts. The patient also has a digital breast tomosynthesis study. In the left upper inner quadrant a spiculated mass is seen.

Pseudoangiomatous stomal hyperplasia (PASH)

Image IQ: 57-year-old with Dense Breasts, Spiculated Mass

Middle-Aged Man Presents with Left-Sided Weakness

For more coverage based on industry expert insights and research, subscribe to the Diagnostic Imaging e-Newsletter 

Middle age male with left sided weakness. What is the most likely diagnosis? What radiology sign is demonstrated?

Image IQ Quiz: Middle-Aged Man Presents with Left-Sided Weakness

44-year-old female presents with “cord-like,” palpable lump on left breast.

First two images represent color Doppler images of the left breast at the 4:00 position.

Second two images represent color Doppler images in the left breast 4:00 position one month after initial presentation.

Superficial thrombophlebitis (Mondor’s disease)

Image IQ: 44-year-old Female, Cord-Like Breast Lump

What is your diagnosis of this condition as seen on CT?

Martin Spence, Vice President of Service and Support Operations at FUJIFILM Medical Systems USA, Inc.

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