ACR Data Science Institute AI Central has been updated with 11 new products. With this latest update, we see many newly cleared FDA products designed for computed tomography (CT) scans of the brain, lung, spine and chest.
New products include:
Rapid Aneurysm Triage and Notification
- Developed by: iSchemaView Inc.
- Rapid Aneurysm Triage and Notification (ANRTN) is a radiological computer-assisted triage and notification software device for analysis of CT images of the head. The device is intended to assist hospital networks and trained radiologists in workflow triage by flagging and prioritizing studies with suspected saccular aneurysms during routine patient care. Rapid ANRTN uses an artificial intelligence algorithm to analyze images and highlight studies with suspected saccular aneurysms in a standalone application for study list prioritization or triage in parallel to ongoing standard of care. The device generates compressed preview images that are meant for informational purposes only and not intended for diagnostic use. The device does not alter the original medical image and is not intended to be used as a diagnostic device. Analyzed images are available for review through the PACS, email and mobile application. When viewed the images are for informational purposes only and not for diagnostic use. The results of Rapid ANRTN, in conjunction with other clinical information and professional judgment, are to be used to assist with triage/prioritization of saccular aneurysm cases. Radiologists who read the original medical images are responsible for the diagnostic decision. Rapid ANRTN is limited to analysis of imaging data and should not be used inlieu of full patient evaluation or relied upon to make or confirm diagnosis. Rapid ANRT is limited to detecting saccular aneurysms at least 4mm in diameter in adults.
- Developed by: Brainomix Limited
- Brainomix 360 Triage ICH is 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. Brainomix 360 Triage ICH uses 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 for diagnostic use beyond notification. Specifically, the device is intended to be used for the triage of non-contrast CT images of the brain acquired from adult patients in the acute setting, within 24 hours of the onset of the acute symptoms, or where this is unclear, since last known well (LKW) time. It is not intended to detect isolated subarachnoid hemorrhage. The device sends notifications to a neurovascular specialist that a suspected intracranial hemorrhage has been identified and recommends review of those images. Images can be previewed through a mobile application. 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. Brainomix 360 Triage ICH is 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: 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 of the views. The device is intended for use as a concurrent reading aid during the acquisition and interpretation of fetal ultrasound images.
- Developed by: Imeka
- ANDI is intended for display of medical images and other healthcare data. It includes functions for image review, basic measurements, planning, and visualization (MPR reconstructions). Modules are available for image processing and atlas-assisted visualization and segmentation, where an output can be generated for use by a system capable of reading DICOM image sets. ANDI is indicated for use in the processing of diffusion-weighted MRI sequences into 3D maps that represent white matter tracts. The information presented by ANDI is for measurement of brain white matter tracts only without making a prediction, diagnosis, or interpretation of brain health. It is the responsibility of the physician to review all clinical information associated with a patient in order to make a diagnosis and to determine next steps in the clinical care of the patient. Typical users of ANDI are medical professionals, including but not limited to neurologists and radiologists. ANDI should be used only as adjunctive information. The decision made by trained medical professionals will be considered final. It is not a diagnostic aid.
Argus Cognitive ReVISION Software Application
- Developed by: Argus Cognitive
- Indications for use of the Argus Cognitive ReVISION Software are quantification and reporting of right ventricle (RV) structures and function of patients (adults only) with suspected disease to support physicians’ diagnosis.
syngo.CT Lung CAD (Version VD30)
- Developed by: Siemens Healthineers
- syngo.CT Lung CAD device is a computer-aided detection (CAD) tool designed to assist radiologists in the detection of solid and subsolid pulmonary nodules during review of multi-detector computed tomography (MDCT) from multivendor examinations of the chest. The software is an adjunctive tool to alert the radiologist to regions of interest (ROI) that may be otherwise overlooked. The syngo.CT Lung CAD device may be used as a concurrent first reader followed by a full review of the case by the radiologist or as second reader after the radiologist has completed his/her initial read. The syngo.CT Lung CAD device may also be used in 'solid-only' mode, where potential (or suspected) sub-solid and/or fully calcified CAD findings are filtered out. The software device is an algorithm which does not have its own user interface component for displaying of CAD marks. The Hosting Application incorporating syngo.CT Lung CAD is responsible for implementing a user interface.
Fibroid Mapping Reviewer Application (FMRA)
- Developed by: Nesa Medtech Private Limited
- Fibroid Mapping Reviewer Application (FMRA) is intended to be used by physicians in the clinic or hospital to generate a 3-D model from ultrasound images of the uterus of women with uterine fibroids. The model represents clinically relevant dimensions, including the location and dimensions of the fibroid (maximum length, width and depth).
- Developed by: GE Medical Systems
- Spine Auto Views is a non-invasive image analysis software package which may be used in conjunction with CT images to aid in the automatic generation of anatomically focused multi-planar reformats and automatically export results to predetermined DICOM destinations. Spine Auto Views assists clinicians by providing anatomically focused reformats of the spine, with the ability to apply anatomical labels of the vertebral bodies and intervertebral disc spaces. Spine Auto Views may be used for multiple care areas and is not specific to any disease state. It can be utilized for the review of various types of exams including trauma, oncology, and routine body.
- Developed by: Canon Medical Systems
- Open Rib is image analysis software for chest CT images. Open Rib offers a visualization of the unfolded rib cage that allows a physician to instantly view the full rib anatomy and should be used as an additional view in adjunct to conventional multiplanar reformat views. Open Rib offers geometric and HU measurement tools.
- Developed by: Siemens Healthineers
- Open Rib is image analysis software for chest CT images. Open Rib offers a visualization of the unfolded rib cage that allows a physician to instantly view the full rib anatomy and should be used as an additional view in adjunct to conventional multiplanar reformat views. Open Rib offers geometric and HU measurement tools.
- Developed by: DeepLook
- DeepLook PRECISE is a software device that is integrated into medical Image Viewers and PACS workstations to assist trained professionals in measuring dimensions of objects within a region of interest (ROI) that is identified by the user in DICOM images. The generated information consists of an estimated greatest long-axis and greatest short-axis dimensions, area, volume, and margin of the objects. For illustration purposes, DeepLook PRECISE can optionally provide a colorization of the interior area defined by a margin. DeepLook PRECISE does not make clinical decisions nor is a decision-support tool. The information provided by the software is an initial estimate and must not be used in isolation when making patient management decisions. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretation. Mammographic images may only be interpreted using and FDA cleared monitor that offers at least 5 Megapixel resolutions and meets other technical specifications reviewed and accepted by FDA. Typical users of this system are trained physicians and radiologists. DeepLook PRECISE, is not intended for use on mobile devices.
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.