ACR Data Science Institute’s AI Central has been updated with eight new products. With this latest update, we see newly cleared FDA products designed for CT and MR scans of the brain.
New products include:
Brainomix 360 e-MRI
- 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 diffusion weighted 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: Terran Biosciences, Inc.
- Terran NM-101 is a post-processing software medical device intended for use in visualization of the brain in older adults between the age of 51 to 83 years. Terran NM-101 analyzes input data acquired from Siemens 3T MR imaging systems, using a specified protocol (i.e., Turbo Spin Echo, TSE). Terran NM-101 can generate qualitative parametric maps from non-contrast T1-weighted image MR acquisition. Terran NM-101 is also intended for automatic labeling, visualization, volumetric quantification and contrast quantification of segmentable brain tissues from a set of Siemens 3T acquired MR images. Brain tissue characterization and volumes of neuromelanin associated signal contrasts are determined based on analysis of qualitative parametric maps. When interpreted by a neuroradiologist, Terran NM-101 images can provide information useful in determining neuromelanin association as an adjunct to diagnosis. Terran NM-101 must always be used in combination with a T1-weighted image MR acquisition.
- Developed by: Brainomix Limited
- Brainomix Triage LVO 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 Triage LVO 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 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 (LVO) has been identified and recommends review of those images. Images can be previewed through a mobile application or via email. Brainomix Triage 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 noncompressed 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 Triage LVO 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: Qure.ai Technologies
- qXR-CTR is a deep-learning based software for use by hospitals and clinics for automated assessment of the CTR on chest X-ray (CXRs) scans. qXR-CTR is designed to measure the ratio of the maximal transverse diameter of the heart (CD) and the maximal inner transverse diameter (TD) of the thoracic cavity and calculate the CTR value on posterior-anterior view chest view using an artificial intelligence algorithm. The intended users of this device are physicians or licensed practitioners in healthcare institutions, such as clinics, hospitals, residential care facilities, long-term care services, and healthcare facilities. The system is suitable for adults ≥ 22 years of age. The device is used to aid the intended users and results are not intended to be used on a stand-alone basis for clinical decision making or otherwise preclude clinical assessment of CTR cases.
- Developed by: AI Medical AG
- Jazz is intended for the labeling, visualization and volumetric quantification of segmentable brain structures from a set of MR images, for patients with a known diagnosis of multiple sclerosis (for the multiple sclerosis pipeline) and/or brain metastasis (for the metastasis pipeline), and the production of a radiological report.
Annalise Enterprise CTB Triage Trauma- Vasogenic edema
- 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: vasogenic edema 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 a specific finding, or otherwise preclude clinical assessment of CTB studies Intended modality: Annalise Enterprise identifies the suspected finding 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.
Annalise Enterprise CTB Triage Trauma- Mass Effect
- 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: • mass effect 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 a specific finding, or otherwise preclude clinical assessment of CTB studies Intended modality: Annalise Enterprise identifies the suspected finding 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.
- Developed by: Combinostics Oy
- cNeuro cPET aids physicians in the evaluation of patient pathologies via assessment and quantification of PET brain scans. The software aids in the assessment of human brain PET scans enabling automated analysis through quantification of tracer uptake and comparison with the corresponding tracer uptake in normal subjects. The resulting quantification is presented using volumes of interest and voxel-based maps of the brain. cNeuro cPET allows the user to generate information regarding relative changes in PET-FDG glucose metabolism. cNeuro cPET additionally allows the user to generate information regarding relative changes in PET brain amyloid load between a subject’s images and a normal database, which may be the result of brain neurodegeneration. PET co-registration and fusion display capabilities with MRI allow PET findings to be related to brain anatomy. cNeuro cPET aids physicians in the image interpretation of PET studies conducted on patients being evaluated for cognitive impairment, or other causes of cognitive decline.
- Developed by: Alpha Intelligence Manifolds, Inc.
- DeepXray is a radiological fully automated image processing software device of either computed (CR) or directly digital (DX) images intended to aid medical professionals in the measurement of minimum joint space width; the assessment of the presence or absence of sclerosis, joint space narrowing, and osteophytes based on OARSI criteria for these parameters; and, the presence or absence of radiographic knee OA based on Kellgren & Lawrence Grading of standing, fixed-flexion radiographs of the knee. It should not be used in-lieu of full patient evaluation or solely relied upon to make or confirm a diagnosis. The system is to be used by trained professionals including, but not limited to, radiologists, orthopedists, physicians and medical technicians.
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.