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CMS Must Provide Coverage for Breakthrough Medical Technologies  

Emphasizing enhanced workflow efficiency for mammography exams, GE HealthCare will unveil the Pristina Via mammography platform at the Radiological Society of North America (RSNA) conference.

In addition to offering zero-click acquisition to facilitate streamlined workflow, the 

 incorporates prior image comparison, irrespective of mammography vendor, to aid in mammography assessments, according to GE HealthCare.

The company adds that the Pristina Via system offers image to image cycle time for digital breast tomosynthesis (DBT) that is up to twice as fast as other mammography platforms, as well as the lowest radiation dose for all breast thicknesses.

“Simplifying, automating, and streamlining the mammography exam to improve in-room workflows is critical to driving patient compliance and access to screening,” said John Simon, M.D., the CEO of SimonMed. “The enhancements offered by Pristina Via are part of our mission of making advanced technology accessible.”

The new mammography system reportedly offers features that promote workflow efficiency as well as patient comfort.

Topic

GE HealthCare Introduces Pristina Via Mammography System at RSNA

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 “

FDA Clears Software for Enhancing CCTA Assessment of Atherosclerosis

Coronary CT Angiography Study Shows Link Between Major Cardiovascular Events and High Lipid Core Burden

Meta-Analysis Shows Superiority of CT Angiography Over SPECT and Functional Testing for Obstructive CAD

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.

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

Emerging tau positron emission tomography (PET) research suggests that modifications of body mass index (BMI), hypertension and educational level may have an impact in curtailing the progression of Alzheimer’s disease (AD), noted Merle Hoenig, Ph.D, in a recent interview at the 

Society for Nuclear Medicine and Molecular Imaging (SNMMI) conference

For the study, Dr. Hoenig and her colleagues reviewed tau volume maps from longitudinal 

F-AV-1451 PET scans in a cohort of 162 amyloid-positive study participants. The cohort included 55 people with mild cognitive impairment, 30 participants with AD and 77 people with no cognitive impairment, according to the study.

Dr. Hoenig said the research findings revealed that women and those with the e4 allele of the Apolipoprotein E gene (ApoE4), a key risk factor for AD, had greater tau speed (spatial progression) over time whereas modifiable factors, such as education, hypertension and BMI, affect tau level rise (local tau amplification).

“We believe that, in particular, genetics are more closely related to the spatial progression whereas those modifiable factors are more linked to the increase of tau pathology at certain regions,” noted Dr. Hoenig, a postdoctoral researcher at the Julich Research Center in Julich, Germany.

(Editor’s note: For additional research from the SNMMI conference, click 

Dr. Hoenig suggested that closer examination of tau speed as well as tau level rise may provide additional insights into emerging treatments for AD.

“(When) you consider both aspects of tau pathology, so the tau speed as well as the tau level rise, it might provide a bit more refined means to have a look at the efficacy of these novel AD drug compounds that are currently tested in the clinics,” posited Dr. Hoenig, a postdoctoral researcher at the Julich Research Center in Julich, Germany.

New Study Shows Impact of Tau-Positive PET in Risk Stratification for Dementia and Alzheimer’s Disease

A Closer Look at the New Appropriate Use Criteria for Brain PET: An Interview with Philip Kuo, MD, Part 2

New PET and MRI Research Suggests that Visceral Fat Reduction May Prevent or Delay Alzheimer’s Disease

For more insights from Dr. Hoenig, watch the video below.

In a recent interview at SNMMI conference, Merle Hoenig, Ph.D., discussed new tau PET research examining genetic and modifiable risk factors that contribute to the progression of Alzheimer’s disease.

SNMMI: What Tau PET Findings May Reveal About Modifiable Factors for Alzheimer’s Disease

Hoenig M, Dzialas V, Doering E, Bischof G, Van Eimeren T, Drzezga A. The speed limits of tau pathology progression in Alzheimer’s disease. Presented at the Society for Nuclear Medicine and Molecular Imaging (SNMMI) conference, June 21-24, 2025, New Orleans. Available at: 

https://jnm.snmjournals.org/content/66/supplement_1/251040

A 72 year-old woman presents for routine screening mammogram with no complaints.

Image IQ: 72 year-old Female, Focal Asymmetry in Breast

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)

Jessica Foley, Ph.D., Chief Science Officer, Focused Ultrasound Foundation

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