ACR Data Science Institute’s AI Central has been updated with four new products. With this latest update, we see newly cleared FDA products designed for CT and MR scans of the brain.
New products include:
- Developed by: Brainomix Limited
- Brainomix 360 e-MRI 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. This includes DICOM files uploaded through a web browser interface. Brainomix 360 e-MRI provides both viewing and analysis capabilities for imaging datasets acquired with MRI including Perfusion Weighted Imaging (PWI) and Diffusion Weighted Imaging (DWI). The DWI MRI analysis capabilities are used to visualize local water diffusion properties from the analysis of diffusionweighted MRI data. The MRI PWI analysis capabilities are 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.
- Developed by: AIRAMed
- AIRAscore is intended for automatic labeling, visualization and volumetric quantification of segmentable brain structures from a set of MR images. This software is intended to automate the current manual process of identifying, labeling and quantifying the volume of segmentable brain structures identified on MR images.
- Developed by: Qure.ai Technologies
- qXR-PTX-PE 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). qXR-PTX-PE uses an artificial intelligence algorithm to analyze images for features suggestive of critical findings and provides case-level output available in the PACS/workstation for worklist prioritization or triage. As a passive notification for prioritization-only software tool within standard of care workflow, qXR-PTX-PE does not send a proactive alert directly to the appropriately trained medical specialists. qXR-PTX-PE is not intended to direct attention to specific portions of an image or to anomalies other than pleural effusion and/or pneumothorax. Its results are not intended to be used on a stand-alone basis for clinical decision-making.
- Developed by: Annalise-AI Pty Ltd.
- Intended context 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 finding: - obstructive hydrocephalus The device analyzes studies using an artificial intelligence algorithm to identify the finding. 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 the suspected finding. 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. Intended user 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. Intended patient population The intended population is patients who are 22 years or older.
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.