AI Central Market Updates for June 12, 2024

ACR Data Science Institute’s AI Central has been updated with 6 new products to the directory. 

New Imaging AI Products 

Our AI Central directory has also been updated with 6 new products. This information is pulled directly from FDA 510K documents and updated by ACR staff. With this latest update, we see many newly cleared FDA products designed for chest ultrasounds and CT scans. 

New products include:  

True Enhance DL 

• Developed by: GE HealthCare
• True Enhance DL is a deep learning-based image processing method trained to estimate monochromatic, 50 keV GSI images. The algorithm is intended to improve the contrast of 120 kVp, single energy images of the body. This device is intended to provide non-quantitative, adjunct information and should not be interpreted without the original 120 kVp image. True Enhance DL may be used for patients of all ages.

Us2.v2

• Developed by: US2.AI 
• Us2.v2 software is used to process acquired transthoracic cardiac ultrasound images, to analyze and make measurements on images in order to provide automated estimation of several cardiac structural and functional parameters, including left/ right atrial and ventricular linear dimensions, volumes, systolic function and diastolic function, measured by B mode, M mode and Doppler (PW, CW, tissue) modalities. The data produced by this software is intended to be used to support qualified cardiologists, sonographers, or other licensed professional healthcare practitioners for clinical decision-making. Us2.v2 is indicated for use in adult patients. Please note the following limitations: - Poor image capture will lead to poor annotations and subsequent measurements. Multiple image quality algorithms are used to filter out images of poor quality. - Our software complements good patient care and does not exempt the user from the responsibility to provide supervision, clinically review the patient, and make appropriate clinical decisions. - If no gender is present, female referenced guideline values will be used for conclusions. - If Body Surface Area (BSA) is not present, indexed values cannot be provided. - During image acquisition, inappropriate use of the echo machine, use of non-cardiac ultrasound probes, use of suboptimal settings (e.g. gain, contrast, depth), or lack of electrocardiogram capture may lead to lower accuracy of the software.

EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEM

• Developed by: Ever Fortune.AI Co., Ltd.
• EFAI CARDIOSUITE CTA ACUTE AORTIC SYNDROME ASSESSMENT SYSTEM (EFAI AASCTA) is a radiological computer aided triage and notification software indicated for use in the analysis of chest or chest-abdomen CTA in adults aged 22 and older. The device is intended to assist hospital networks and appropriately trained medical specialists in workflow triage by flagging and communicating suspected positive cases of aortic dissection (AD) or aortic intramural hematoma (IMH) pathology. EFAI AASCTA uses an artificial intelligence algorithm to identify suspected findings. It makes case-level output available to a PACS/workstation for worklist prioritization or triage. BFAI AASCTA is not intended to direct attention to specific portions or anomalies of an image. Its results are not intended to be used on a stand-alone basis for clinical decision- making nor is it intended to rule out AAS or otherwise preclude clinical assessment of computed tomography angiography cases.

Rapid

• Developed by: RapidAI
• Rapid is an image processing software package to be used by trained professionals, including but not limited to physicians (medical analysis and decision making) and medical technicians (administrative case processing). The software runs on a standard off-the-shelf computer or a virtual platform, such as VMware, and can be used to perform image viewing, processing, and analysis of images. Data and images are acquired through DICOM compliant imaging devices. Rapid is indicated for use in Adults only. Rapid provides both viewing and analysis capabilities for functional and dynamic imaging datasets acquired with CT, CT Perfusion (CTP), CT Angiography (CTA), C-arm CT Perfusion and MRI including a Diffusion Weighted MRI (DWI) Module and a Dynamic Analysis Module (dynamic contrast-enhanced imaging data for MRI, CT, and C-arm CT). Rapid C-arm CT Perfusion can be used to qualitatively assess cerebral hemodynamics in the angiography suite. The CT analysis includes NCCT maps showing areas of hypodense and hyperdense tissue. The DWI Module is used to visualize local water diffusion properties from the analysis of diffusion - weighted MRI data. The Dynamic Analysis Module is used for visualization and analysis of dynamic imaging data, showing properties of changes in contrast over time. This functionality includes calculation of parameters related to tissue flow (perfusion) and tissue blood volume. Rapid CT Perfusion and Rapid MR Perfusion can be used by physicians to aid in the selection of acute stroke patients (with known occlusion of the intracranial internal carotid artery or proximal middle cerebral artery). Instructions for the use of contrast agents for this indication can be found in Appendix A of the User’s Manual. Additional information for safe and effective drug use is available in the product-specific iodinated CT and gadolinium-based MR contrast drug labeling. In addition to the Rapid imaging criteria, patients must meet the clinical requirements for thrombectomy, as assessed by the physician, and have none of the following contraindications or exclusions: • Bolus Quality: absent or inadequate bolus. • Patient Motion: excessive motion leading to artifacts that make the scan technically inadequate. • Presence of hemorrhage. • C-Arm CTP is not to be used in the Rapid Thrombectomy indication for patient selection criteria, other modalities should be consulted. Cautions: • C-Arm CTP provides qualitative data only, review other modalities prior to diagnosis. CBV and CBT are not absolute and CBT, CBV, MTT and Tmax are supported for qualitative interpretation of the perfusion maps only.

InVision Precision LVEF (LVEF)

• Developed by: InVision Medical Technology Corporation
• In Vision Precision LVEF is used to process previously acquired trans thoracic cardiac ultrasound images, store images, and manipulate and make measurements on images using an ultrasound device, personal computer, or a compatible DICOM compliant PACS system to provide an automated estimation of LVEF. This measurement can be used to assist the clinician in a cardiac evaluation. In Vision Precision is indicated for use in patients 22 years and older by sonographers and physicians evaluating cardiac ultrasound.

Sonio Detect

• Developed by: Sonio
• Sonio Detect is intended to analyze fetal ultrasound images and clips using machine learning techniques to automatically detect views, detect anatomical structures within the views and verify quality criteria and characteristics of the views. The device is intended for use as a concurrent reading aid during the acquisition and interpretation of fetal ultrasound images