ACR Data Science Institute’s AI Central had a busy month, adding 13 new products to the directory. Plus, eight products were updated.
Manufacturer Updates
For our first update, two manufacturers have provided information about their products in collaboration with the ACR Data Science Institute so AI Central users can better understand their offerings. GE HealthCare added a new product to the marketplace this month and Siemens Healthineers updated one of their products.
Developed by GE HealthCare: CardIQ Suite
- CardlQ Suite is a non-invasive software application designed to provide an optimized application to analyze cardiovascular anatomy and pathology based on 2D or 3D CT cardiac non contrast and angiography DICOM data from acquisitions of the heart. It provides capabilities for the visualization and measurement of vessels and visualization of chamber mobility. CardlQ Suite also aids in diagnosis and determination of treatment paths for cardiovascular diseases to include, coronary artery disease, functional parameters of the heart, heart structures and follow-up for stent placement, bypasses and plaque imaging. CardlQ Suite provides calcium scoring, a non-invasive software application, that can be used with non-contrasted cardiac images to evaluate calcified plaques in the coronary arteries, heart valves and great vessels such as the aorta. Calcium Scoring may be used to monitor the progression/regression of calcium in coronary arteries overtime, which may aid in the prognosis of cardiac disease.
Developed by Siemens Healthineers: syngo.CT applications
- syngo.CT Applications is a set of software applications for advanced visualization, measurement, and evaluation for specific body regions. This software package is designed to support the radiologists and physicians from emergency medicine, specialty care, urgent care, and general practice e.g. in the: Evaluation of perfusion of organs and tumors and myocardial tissue perfusion; Evaluation of bone structures and detection of bone lesions; Evaluation of CT images of the heart; Evaluation of the coronary lesions; Evaluation of the mandible and maxilla; Evaluation of dynamic vessels and extended phase handling; Evaluation of the liver and its intrahepatic vessel structures to identify the vascular territories of sub-vessel systems in the liver; Evaluation of neurovascular structures; Evaluation of the lung parenchyma; Evaluation of non-enhanced Head CT images; and Evaluation of vascular lesions.
ACR DSI collaborates with manufacturers to explain how their products work on AI Central in an effort to improve patient care and make it easier to learn more. This gives radiologists a better understanding of how a product can best support their patients and workflows through supplemental material about each product developed by the manufacturer.
New Imaging AI Products
Our AI Central directory has also been updated with 13 new products, including GE HealthCare’s new product mentioned above. 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 x-rays.
New products include:
- Developed by: AI4MedImaging Medical Solutions S.A.
- AI4CMR software is designed to report cardiac function measurements (ventricle volumes, ejection fraction, indices etc.) from 1.5T and 3T magnetic resonance (MR) scanners. AI4CMR uses artificial intelligence to automatically segment and quantify the different cardiac measurements. Its results are not intended to be used on a stand-alone basis for clinical decision-making. The user incorporating AI4CMR into their DICOM application of choice is responsible for implementing a user interface.
- Developed by: HeartLung Corporation
- The Automated Bone Mineral Density Software Module (ABMD) is a post-processing Al-powered software intended to measure bone mineral density (BMD) from existing CT scans by averaging Hounsfield units in the trabecular region of vertebral bones. ABMD is not intended to replace DXA or any other tests dedicated to BMD measurement. It is solely designed for measuring BMD in existing CT scans or CT scans ordered for reasons other than BMD measurement. In summary, ABMD is an opportunistic Al-powered tool that enables: (1) retrospective assessment of bone density from CT scans acquired for other purposes, (2) assessment of bone density in conjunction with another medically appropriate procedure involving CT scans, and (3) assessment of bone density without a phantom as an independent measurement procedure.
- Developed by: ClariPi Inc.
- ClariSIGMAM is a software application intended for use with compatible full field digital mammography systems. ClariSIGMAM calculates percent breast density defined as the ratio of fibroglandular tissue to total breast area estimates. ClariSIGMAM uses this numerical value to provide breast density group information (BI-RADS A+B as fatty and BI- RADS C+D as dense) to aid interpreting physicians in the assessment of breast tissue composition. ClariSIGMAM produces adjunctive information. It is not a diagnostic aid.
- Developed by: Imagen Technologies, Inc
- Aorta-CAD is a computer-assisted detection (CADe) software device that analyzes chest radiograph studies for suspicious regions of interest (ROIs). The device uses a deep learning algorithm to identify ROIs and produces boxes around the ROIs. The boxes are labeled with one of the following radiographic findings: Aortic calcification or Dilated aorta. Aorta-CAD is intended for use as a concurrent reading aid for physicians looking for ROIs with radiographic findings suggestive of Aortic Atherosclerosis or Aortic Ectasia. It does not replace the role of the physician or of other diagnostic testing in the standard of care. Aorta-CAD is indicated for adults only.
- Developed by: Dyad Medical
- Libby Echo:Prio is software that is used to process previously acquired DICOM-compliant cardiac ultrasound images, and to make measurements on these images in order to provide automated estimation of several cardiac measurements. 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. Libby Echo:Prio is indicated for use in adult patients.
EFAI Intelligent Cardiothoracic Ratio (iCTR) Assessment System
- Developed by: Ever Fortune.AI Co., Ltd.
- EFAI Intelligent Cardiothoracic Ratio Assessment System (or iCTR) is a software for use by hospital and clinics to automatically assess the cardiothoracic ratio (CTR) of a chest X-ray image from the X-ray imager subject. The iCTR is designed to measure the maximal transverse diameter of heart and maximal inner transverse diameter of thoracic cavity and calculate the CTR of a chest X-ray image in posterior-anterior (PA) chest view using an artificial intelligence algorithm. Intended users of the software are aimed to the physicians or other licensed practitioners in the healthcare institutions, such as clinics, hospitals, healthcare facilities, residential care facilities and long-term care services. The system is suitable for adults between 20 - 80 years of age. Its results are not intended to be used on a stand-alone basis for clinical-decision making or otherwise preclude clinical assessment of cardiothoracic ratio (CTR) cases.
- Developed by: Imagen Technologies, Inc
- Chest-CAD is a computer-assisted detection (CADe) software device that analyzes chest radiograph studies using machine learning techniques to identify, categorize, and highlight suspicious regions of interest (ROI). Any suspicious ROI identified by Chest-CAD is assigned to one of the following categories: Cardiac, Mediastinum/Hila, Lungs, Pleura, Bones, Soft Tissues, Hardware, or Other. The device is intended for use as a concurrent reading aid for physicians. Chest-CAD is indicated for adults only.
- Developed by: Hologic, Inc.
- The Quantra™ software application is intended for use with mammographic images acquired using digital breast x-ray systems. The Quantra software segregates breast density into categories, which may be useful in the reporting of consistent BI-RADS® breast composition categories as mandated by certain state regulations. The Quantra software reports a result for each subject, which is intended to aid radiologists in the assessment of breast tissue composition. The Quantra software produces adjunctive information; it is not a diagnostic aid.
Powerlook Tomo Detection V2 Software
- Developed by: iCAD
- PowerLook® Tomo Detection V2 Software is a computer-assisted detection and diagnosis (CAD) software device intended to be used concurrently by interpreting physicians while reading digital breast tomosynthesis (DBT) exams from compatible DBT systems. The system detects soft tissue densities (masses, architectural distortions and asymmetries) and calcifications in the 3D DBT slices. The detections and Certainty of Finding and Case Scores assist interpreting physicians in identifying soft tissue densities and calcifications that may be confirmed or dismissed by the interpreting physician.
- Developed by: DASI Simulations
- DASI Dimensions is a standalone, non-invasive, clinical decision support software solution that is intended for use by cardiologists and radiologists in context of the aortic stenosis population. DASI Dimensions provides the end-user with pre-defined images and measurements (diameters, lengths, angles, areas, and perimeters) of cardiovascular structures. The clinician receiving the results retains the responsibility for interpreting and validating all information and making all patient treatment decisions. DASI Dimensions is not intended to replace the clinician's decision or device's instructions for use. DASI Dimensions is prescription use only.
- Developed by: Envisionit DeepAI Ltd
- RADIFY® Triage is a radiological computer-assisted triage and notification software that analyzes adult chest X-ray images for the presence of pre-specified suspected critical findings (pleural effusion and/or pneumothorax). RAD I FY® Triage uses an artificial intelligence algorithm to analyze images for features suggestive of critical findings and provides case-level output available in the PACS for worklist prioritization or triage. As a passive notification for prioritization-only software tool within the standard of care workflow, RADIFY® Triage does not send a proactive alert directly to the appropriately trained medical specialists. The product is not intended to direct attention to specific portions of an image. Its results are not intended to be used on a stand-alone basis for clinical decision-making. The device does not remove the cases from the queue and does not flag the condition as being absent.
Radify® Triage- Pleural Effusion
- Developed by: Envisionit DeepAI Ltd
- RADIFY® Triage is a radiological computer-assisted triage and notification software that analyzes adult chest X-ray images for the presence of pre-specified suspected critical findings (pleural effusion and/or pneumothorax). RAD I FY® Triage uses an artificial intelligence algorithm to analyze images for features suggestive of critical findings and provides case-level output available in the PACS for worklist prioritization or triage. As a passive notification for prioritization-only software tool within the standard of care workflow, RADIFY® Triage does not send a proactive alert directly to the appropriately trained medical specialists. The product is not intended to direct attention to specific portions of an image. Its results are not intended to be used on a stand-alone basis for clinical decision-making. The device does not remove the cases from the queue and does not flag the condition as being absent.
New Imaging AI Product Updates
Our AI Central directory was also updated with new versions of some imaging AI products.
Products that have new updates include:
- Developed by: Hyperfine
- BrainInsight is intended for automatic labeling, spatial measurement, and volumetric quantification of brain structures from a set of low-field MR images and returns annotated and segmented images, color overlays and reports.
- Developed by: Viz.ai, Inc.
- Viz LVOis a notification-only, parallel workflow tool for use by hospital networks and trained clinicians to identify and communicate images of specific patients to a specialist, independent of standard of care workflow. Viz LVOuses an artificial intelligence algorithm to analyze images for findings suggestive of a prespecified clinical condition and to notify an appropriate medical specialist of these findings in parallel to standard of care image interpretation. Identification of suspected findings is not fordiagnostic use beyond notification. Specifically, the device analyzes CT angiogram images of the brain acquired in the acute setting, and sends notifications to a neurovascular specialist that a suspected large vessel occlusion has been identified and recommends review of those images. Images can be previewed through a mobile application.Viz LVO is intended to analyze terminal ICA and MCA-M1 vessels for LVOs. Images that are previewed through the mobile application are compressed and are for informational purposes only and not intended for diagnostic use beyond notification. Notified clinicians are responsible for viewing non-compressed images on a diagnostic viewer and engaging in appropriate patient evaluation and relevant discussion with a treating physician before making care-related decisions or requests. Viz LVOis limited to analysis of imaging data and should not be used in-lieu of full patient evaluation or relied upon to make or confirm diagnosis.
- Developed by: Screenpoint Medical B.V.
- Transpara@ software is intended for use as a concurrent reading aid for physicians interpreting screening full-field digital mammography exams and digital breast tomosynthesis exams from compatible FFDM and DBT systems, to identify regions suspicious for breast cancer and assess their likelihood of malignancy. Output of the device includes locations of calcifications groups and soft-tissue regions, with scores indicating the likelihood that cancer is present, and an exam score indicating the likelihood that cancer is present in the exam. Patient management decisions should not be made solely on the basis of analysis by Transpara@.
- Developed by: iCAD
- ProFound AI® V3.0 is a computer-assisted detection and diagnosis (CAD) software device intended to be used concurrently by interpreting physicians while reading digital breast tomosynthesis (DBT) exams from compatible DBT systems. The system detects soft tissue densities (masses, architectural distortions and asymmetries) and calcifications in the 3D DBT slices. The detections and Certainty of Finding and Case Scores assist interpreting physicians in identifying soft tissue densities and calcifications that may be confirmed or dismissed by the interpreting Physician.
- Developed by: Thirona corporation
- The Thirona LungQ software provides reproducible CT values for pulmonary tissue which is essential for providing quantitative support for diagnosis and follow up examination. The LungQ software can be used to support physician in the diagnosis and documentation of pulmonary tissues images (e.g. abnormalities) from CT thoracic datasets. Three-D segmentation and isolation of sub-compartments, volumetric analysis, density evaluations, fissure evaluation, and reporting tools are provided.
- Developed by: RapidAI
- Rapid ASPECTS is a computer-aided diagnosis (CADx) software device used to assist the clinician in the assessment and characterization of brain tissue abnormalities using CT image data. The Software automatically registers images and segments and analyzes ASPECTS Regions of Interest (ROls). Rapid ASPECTS extracts image data for the ROI(s) to provide analysis and computer analytics based on morphological characteristics. The imaging features are then synthesized by an artificial intelligence algorithm into a single ASPECT (Alberta Stroke Program Early CT) Score. Rapid ASPECTS is indicated for evaluation of adult patients presenting for diagnostic imaging workup, for evaluation of extent of disease. Extent of disease refers to the number of ASPECTS regions affected which is reflected in the total score. This device provides information that may be useful in the characterization of early ischemic brain tissue injury for ischemic stroke patient (typically < 24 hours since last known well) during image interpretation following the standard of care. Rapid ASPECTS provides a comparative analysis to the ASPECTS standard of care radiologist assessment using the ASPECTS atlas definitions and atlas display including highlighted ROls and numerical scoring. Rapid ASPECTS presents the original and annotated images for concurrent reads.
- Developed by: iSchemaView, Inc.
- Rapid is an image processing software package to be used by trained professionals, including but not limited to physicians and medical technicians. 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 provides both viewing and analysis capabilities for functional and dynamic imaging datasets acquired with CT Perfusion (CTP), CT Angiography (CTA), and MRI including a Diffusion Weighted MRI (DWI) Module and a Dynamic Analysis Module (dynamic contrast-enhanced imaging data for MRI and CT). 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