AI Central Market Updates for July 24, 2024

ACR Data Science Institute’s AI Central has been updated with three new Transparent-AI products and three new products to the directory. 

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New Transparent-AI Products

Three new products were added to our Transparent-AI program, which is designed to increase transparency in imaging AI and help end users have better informed discussions and selection criteria when making decisions about which algorithm might be most appropriate for their local target population.   

Perspectum Diagnostics Ltd. joined the Transparent-AI program with their products MRCP+, Hepatica, and LiverMultiScan.

Transparent-AI consists of voluntarily provided data elements solicited from participating imaging AI manufacturers who currently have an FDA-cleared product in the U.S. market. Manufacturers who participate in this program will receive the Transparent-AI badge on their product listing.   

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New Imaging AI Products

Our AI Central directory has also been updated with three new products. This information is pulled directly from FDA 510K documents and updated by ACR staff. With this latest update, we see newly cleared FDA products designed for pediatric x-rays, chest CTs and prostate MR images.

New products include: 

EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100)  

• Developed by: Ever Fortune.AI Co., Ltd. 
• EFAI BONESUITE XR BONE AGE PRO ASSESSMENT SYSTEM (EFAI BAPXR) is designed to view and quantify bone age from 2D Posterior Anterior (PA) view of left-hand radiographs using deep learning techniques to aid in the analysis of bone age assessment of patients between 2 to 16 years old for pediatric radiologists. The results should not be relied upon alone by pediatric radiologists to make diagnostic decisions. The images shall be with left hand and wrist fully visible within the field of view, and shall be without any major bone destruction, deformity, fracture, excessive motion, or other major artifacts. 

Cardiac CT Function Software Application 

• Developed by: Circle Cardiovascular Imaging Inc 
• The Cardiac CT Function Software Application is indicated to be used with multi-phase, multi-slice cardiovascular CT angiography images to assist qualified medical professionals in assessing and evaluating cardiac function. CT Function includes manual and semi-automatic heart segmentation of 2 chambers (LV and RV) and calculation of cardiac function metrics including end diastolic volume, end systolic volume, stroke volume, ejection fraction, cardiac output, cardiac index, and LV myocardial mass. 

Medihub Prostate 

• Developed by: JLK Inc.  
• MEDIHUB PROSTATE is an image processing software package that performs outlining, processing, viewing, and editing of prostate MR images. The software can support study review and analysis of prostate MR data with computed modules. The analysis result can be presented in various formats, including images overlaid onto source MR images and a structured report. MEDIHUB PROSTATE semi-automatically outlines the prostate based on MR images by contour, and it requires the user to edit with image manipulating tools and confirm the final result. The package provides additional functionalities including registered multiparametric-MRI viewing and combining MR sequences into a single image to support visualization. Edited PI-RADS report and semi annotated prostate region can be viewed in each single image in the final report. MEDIHUB PROSTATE is intended to be used by trained radiologists and urologists. Patient management decisions should not be made solely based on the analysis performed by MEDIHUB PROSTATE. Limitations: * MEDIHUB PROSTATE has been validated for use with Siemens 3T Vida and Skyra MRI machines. * MEDIHUB PROSTATE is also designed for use with the Siemens 3T T2 MRI series, supporting slice thicknesses ranging from 3.5 mm to 5 mm. * MEDIHUB PROSTATE has been tested on patients aged 55 years and above.