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Penn Medicine is dedicated to improving artificial intelligence to address radiology needs in individual institutions worldwide, both improving performance and patient outcomes.

Radiology and AI for the Developing World

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 “

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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.

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 47-year-old female presents for her annual screening mammogram. The patient has a history of having “multiple moles,” and is otherwise healthy.

Dysplastic nevus syndrome/familial melanoma syndrome

Image IQ: 47-year-old with Multiple Moles, Screening Mammogram

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Image IQ Quiz: Patient Presents with Inadequate Stomach Distension

A large meta-analysis involving over 100 studies and over 25,000 patients revealed robust sensitivity rates for PI-RADS category 3 and higher assessments with the PI-RADS v2.1 system for interpreting prostate magnetic resonance imaging (MRI). However, the meta-analysis authors cautioned that 34 of the reviewed studies had a high risk of bias or concerns about applicability.

For the meta-analysis, recently published in the 

, researchers reviewed data from 117 studies and 25,228 patients with a total of 15,553 prostate lesions in order to assess the utility of the PI-RADS v2.1 system.

The researchers found that PI-RADS category 

 3 assessments with the PI-RADS v2.1 system had patient-level sensitivity and specificity of 96 percent and 43 percent, respectively, for the detection of clinically significant 

 (csPCa). For patients with PI-RADS category 

 3 evaluations, the PI-RADS v2.1 system offered respective patient-level sensitivity and specificity of 88 percent and 66 percent for csPCa, according to the meta-analysis authors.

The meta-analysis findings also revealed cancer detection rates (CDRs) of 83 percent for PI-RADS category 5, 53 percent for PI-RADS category 4, 20 percent for PI-RADS category 3, 6 percent for PI-RADS category 2 and 3 percent for PI-RADS category 1.

“The present data conﬁrm the available evidence regarding the (PI-RADS v2.1) system’s high sensitivity and low CDRs of low PI-RADS categories,” wrote meta-analysis lead author Andrea Nedelcu, M.D., who is affiliated with the Department of Radiology at the University of Freiburg Medical Center in Freiburg, Germany, and colleagues.

Employing the QUADRAS-2 tool for assessing the quality of the reviewed studies, the meta-analysis authors found that 34 of the studies had a high risk of bias or questionable applicability.

For studies deemed to have a high risk of bias, the researchers noted 11 percent lower lesion-level sensitivity in PI-RADS category > 4 assessments (78 percent vs. 89 percent) as well as an 11 percent higher CDR for PI-RADS category > 2 evaluations (15 percent vs. 4 percent) in contrast to studies without a high bias risk.

“ … A considerable proportion (29%) of studies had a high risk of bias and/or high concerns of applicability. These high-risk studies were associated with signiﬁcantly reduced sensitivity and signiﬁcantly increased CDR for PI-RADS category 2 in certain estimates, suggesting potentially ﬂawed estimates resulting from inclusion of investigations with quality issues,” noted Nedelcu and colleagues.

Is PI-RADS Version 2.1 Outdated for Prostate MRI?

MRI-Based Deep Learning Model Bolsters Prediction of PI-RADS 3 and 4 Lesions

Study: Monitoring of Prostate MRI Exams Could Lead to 75 Percent Reduction of Gadolinium Contrast

In regard to limitations of the meta-analysis, the authors acknowledged the lack of a uniform definition for csPCa in the reviewed studies, the lack of PI-RADS v2.1 assessment for those on active surveillance for known PCa and the exclusion of non-English language studies from the meta-analysis.

While a new meta-analysis of the PI-RADS v2.1 criteria showed 96 percent and 88 percent sensitivity rates for PI-RADS category > 3  and PI-RADS category > 4 assessments respectively, researchers noted a high risk of bias in 29 percent of the reviewed studies.

Victor Babatunde, M.D.

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