ACR Data Science Institute AI Central has been updated with seven new products. With this latest update, we see many newly cleared FDA products designed for computed tomography (CT) scans.
New products include:
Annalise Enterprise CTB Triage Trauma
- Developed and sold by: Annalise-AI Pty Ltd.
- Annalise Enterprise is a device designed to be used in the medical care environment to aid in triage and prioritization of studies with features suggestive of the following findings: acute subdural/epidural hematoma, acute subarachnoid hemorrhage, intra-axial hemorrhage, intraventricular hemorrhage. These findings are intended to be used together as one device. The device analyzes studies using an artificial intelligence algorithm to identify findings. It makes study-level output available to an order and imaging management system for worklist prioritization or triage. The device is not intended to direct attention to specific portions of an image and only provides notification for suspected findings. Its results are not intended: to be used on a standalone basis for clinical decision making, to rule out specific findings, or otherwise preclude clinical assessment of CTB studies Intended modality: Annalise Enterprise identifies suspected findings in non-contrast brain CT studies. The device is intended to be used by trained clinicians who, as part of their scope of practice, are qualified to interpret brain CT studies. The intended population is patients who are 22 years or older.
AI-Rad Companion (Cardiovascular)
- Developed and sold by: Siemens Healthineers
- This is an image processing software that provides quantitative and qualitative analysis from previously acquired Computed Tomography DICOM images to support radiologists and physicians from emergency medicine, specialty care, urgent care, and general practice in the evaluation and assessment of cardiovascular diseases. It provides the following functionality: segmentation and volume measurement of the heart, quantification of the total calcium volume in the coronary arteries, segmentation of the aorta, measurement of maximum diameters of the aorta at typical landmarks, and threshold-based highlighting of enlarged diameters. The software has been validated for non-cardiac chest CT data with filtered back projection reconstruction from Siemens Healthineers, GE Healthcare, Philips, and Toshiba/Canon. Additionally, the calcium detection feature has been validated on non-cardiac chest CT data with iterative reconstruction from Siemens Healthineers. Only DICOM images of adult patients are considered to be valid input.
- Developed and sold by: Siemens Healthineers
- This is an image processing software that provides quantitative and qualitative analysis from previously acquired Computed Tomography DICOM images to support radiologists and physicians from emergency medicine, specialty care, urgent care, and general practice in the evaluation and assessment of cardiovascular diseases. It provides the following functionality: segmentation and volume measurement of the heart, quantification of the total calcium volume in the coronary arteries, segmentation of the aorta, measurement of maximum diameters of the aorta at typical landmarks, and threshold-based highlighting of enlarged diameters. The software has been validated for non-cardiac chest CT data with filtered back projection reconstruction from Siemens Healthineers, GE Healthcare, Philips, and Toshiba/Canon. Additionally, the calcium detection feature has been validated on non-cardiac chest CT data with iterative reconstruction from Siemens Healthineers. Only DICOM images of adult patients are considered to be valid input.
- Developed and sold by: Quantib BV
- This is an image post-processing software that provides the user with processing, visualization, and editing of prostate MRI images. The software facilitates the analysis and study review of MR data sets and provides additional mathematical and/or statistical analysis. The resulting analysis can be displayed in a variety of formats, including images overlaid onto source MRI images. Quantib Prostate functionality includes registered multiparametric-MRI viewing, with the option to view images combined into a single image to support visualization. The software can be used for semi-automatic segmentation of anatomical structures and provides volume computations, together with tools for manual editing. PI-RADS scoring is possible using a structured workflow. Quantib Prostate is intended to be used by trained medical professionals and provides information that, in a clinical setting, may assist in the interpretation of prostate MR studies. Diagnosis should not be made solely based on the analysis performed using Quantib Prostate.
Deep Learning Image Reconstruction
- Developed and sold by: GE Medical Systems
- This software is a deep learning-based reconstruction method intended to produce cross-sectional images of the head and whole body by computer reconstruction of x-ray transmission data taken at different angles and planes, including Axial, Helical (Volumetric), and Cardiac acquisitions, for all ages. Deep Learning Image Reconstruction software can be used for head, whole body, cardiac, and vascular CT applications.
ViewFinder Software Version 1.1
- Developed and sold by: Elaitra Ltd
- This is a dedicated softcopy review environment for both screening and diagnostic digital breast tomosynthesis. Its user interface and workflow have been optimized to support qualified interpreting physicians in both screening and diagnostic reading. Efficiency and reading quality are supported by various specialized features. ViewFinder provides visualization and image enhancement tools to aid a qualified interpreting physician in the review of digital breast tomosynthesis datasets. The qualified interpreting physician is responsible for making the diagnosis of the images presented.
- Developed and sold by: Bunkerhill, Inc.
- This is a software device intended for use in estimating presence and quantity of coronary artery calcium for patients aged 30 years and above during routine care. The device automatically analyzes non-gated, non-contrast chest computed tomography (CT) images collected during routine care and outputs a visual representation of estimated coronary artery calcium segmentation (intended for informational purposes only) and both exact and four-category quantitative estimates of the patient’s coronary artery calcium burden in Agatston units. The output of the subject device is made available to the physician on-demand as part of his or her standard workflow. The device generated calcium score or score group can be viewed in the patient report at the discretion of the physician, and the physician also has the option of viewing the device-generated calcium segmentation in a diagnostic image viewer. The subject device output in no way replaces the original patient report or the original chest CT scan; both are still available to be viewed and used at the discretion of the physician. The device is intended to provide information to the physician to provide assistance during review of the patient’s case. Results of the subject device are not intended to be used on a stand-alone basis and are solely intended to aid and provide information to the physician. In all cases, further action taken on a patient should only come at the recommendation of the physician after further reviewing the patient’s results.
About AI Central: The AI Central database is intended to provide easy-to-access, detailed information regarding FDA cleared AI medical products related to radiology and other imaging domains and is frequently updated with new products and features. AI Central’s editorial board and staff continuously review data from FDA public facing documents, vendor information and physician feedback to provide users with up-to-date information to help make appropriate purchasing decisions.