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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

GE HealthCare launched Flyrcado™ (flurpiridaz F 18) at the recent American College of Cardiology (ACC) conference. A positron emission tomography myocardial perfusion imaging (PET MPI) agent for coronary artery disease (CAD) detection, Flyrcado offers ready to use unit dosing and a half-life that is reportedly 10 times higher than that of other cardiac positron emission tomography (PET) agents.

In research presented at the 2023 Society for Nuclear Medicine and Molecular Imaging (SNMMI) conference

, Flyrcado demonstrated higher sensitivity and specificity rates than single photon emission computed tomography (SPECT) imaging for the detection of CAD in patients with high body mass index (BMI).

, Flyrcado may facilitate enhanced assessment of ischemia through a combination of exercise stress testing and cardiac PET imaging, according to GE HealthCare, the manufacturer of Flyrcado.

“The launch of Flyrcado represents a significant advancement in cardiac care, providing a new, highly effective diagnostic tool for those with known or suspected coronary artery disease,” said Eric Ruedinger, the vice president and general manager of GE HealthCare’s Pharmaceutical Diagnostics segment for the U.S. and Canada.

 recently garnered pass-through payment status from the Centers for Medicare and Medicaid Services (CMS). GE HealthCare said the pass-through payment status, which goes into effect on April 1, 2025, allows separate reimbursement for the radiopharmaceutical and the PET imaging.

The positron emission tomography myocardial perfusion imaging (PET MPI) agent, which offers a significantly higher half-life than other cardiac PET agents, was recently granted pass-through payment status by CMS that will go into effect on April 1, 2025.

GE HealthCare Launches PET MPI Agent Flyrcado at ACC Conference

Case submitted by: Saeed Rad M.D., radiologist, to radRounds Radiology Network

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Geraldine Liao, MD

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