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The e-Lung software provides reproducible CT values for pulmonary tissue, which is essential for providing quantitative support in the examination of radiological findings. These radiological findings can then be evaluated by the physician in conjunction with a range of ancillary information to form a potential diagnosis or list of likely diagnoses. The e-Lung software package is intended to be a workflow enhancement and visualization tool for the assessment of CT thoracic datasets. e-Lung can be used to support the physician when examining the pulmonary and thoracic tissue (i.e. lung parenchyma) in CT thoracic datasets. 3D segmentation, volumetric measurements, density evaluations, and reporting tools are combined with a dedicated workflow.

Brainomix 360 e-Lung is a software package compliant with the DICOM standard and running on an off-the-shelf physical or virtual server. e-Lung is a CT processing module which operates within the integrated Brainomix 360 platform. Brainomix 360 e-Lung is a stand-alone software device which uses a set of image processing algorithms to perform evaluation (3D segmentation and isolation of sub-compartments, volumetric measurements, and density evaluations), editing, and reporting tools which are combined with a dedicated workflow. e-Lung can be used to support the physician in the documentation of radiological findings that may be indicative of chest diseases when examining the pulmonary and thoracic tissue (i.e. lung parenchyma) in CT thoracic datasets. These radiological findings are then evaluated in conjunction with a range of ancillary information to form a potential diagnosis or list of likely diagnoses. e-Lung is designed to analyze pulmonary CT slice data and display analysis results. Each voxel of the scan is measured by Hounsfield units (HU), a measurement of x-ray attenuation that is applied to each volume element in three-dimensional space. The HU are utilized to distinguish between air, water, tissue and bone, such distinction is common in the industry. e-Lung provides computed tomography (CT) viewing, and parenchymal density analysis in one application. e-Lung provides quantitative measurements and tabulates quantitative properties. e-Lung focuses on what is visible to the eye and applies volumetric methods that might otherwise be too time consuming to use. The software does not perform any function which cannot be accomplished by a trained user utilizing manual tracing methods; the software does not reconstruct a 3D rendering image of the lung; the intent of the software is to enhance the workflow by saving time and automating potential error prone manual tasks. e-Lung has functions for loading, and saving datasets, and will generate screen displays, computations and aggregate statistics. e-Lung data output may be exported to a CSV, Excel or PDF file.

Brainomix 360 e-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 uses an atlas to segment and analyze ASPECTS regions. Brainomix 360 e-ASPECTS extracts image data from individual voxels in the image to provide analysis and computer analytics and relates the analysis to the atlas defined ASPECTS regions. The imaging features are then synthesized by an artificial intelligence algorithm into a single ASPECTS (Alberta Stroke Program Early CT) score. Brainomix 360 e-ASPECTS is indicated for evaluation of 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. Brainomix 360 e-ASPECTS provides information that may be useful in the characterization of ischemic brain tissue injury during image interpretation (within 24 hours from time last known well). Brainomix 360 e-ASPECTS provides a comparative analysis to the ASPECTS standard of care radiologist assessment by providing highlighted ASPECTS regions and an automated editable ASPECTS score for clinician review. Brainomix 360 e-ASPECTS additionally provides a visualization of the voxels contributing to and excluded from the automated ASPECTS score, and a calculation of the voxel volume contributing to ASPECTS score. Limitations: 1. Brainomix 360 e-ASPECTS is not intended for primary interpretation of CT images. It is used to assist physician evaluation. 2. The Brainomix 360 e-ASPECTS score should be only used for ischemic stroke patients following the standard of care. 3. Brainomix 360 e-ASPECTS has only been validated and is intended to be used in patient populations aged over 21 years. 4. Brainomix 360 e-ASPECTS is not intended for mobile diagnostic use. Images viewed on a mobile platform are compressed preview images and not for diagnostic interpretation. 5. Brainomix 360 e-ASPECTS has been validated and is intended to be used on Siemens Somatom Definition scanners. Contraindications/ Exclusions/Cautions: · Patient motion: Excessive patient motion leading to artifacts that make the scan technically inadequate. · Hemorrhagic Transformation, Hematoma.

Brainomix 360 e-ASPECTS (also referred to as e-ASPECTS in this submission) is a medical image visualization and processing software package compliant with the DICOM standard and running on an off-the-shelf physical or virtual server. Brainomix 360 e-ASPECTS allows for the visualization, analysis and post-processing of DICOM compliant Non-contrast CT (NCCT) images which, when interpreted by a trained physician or medical technician, may yield information useful in clinical decision making. Brainomix 360 e-ASPECTS is a stand-alone software device which uses machine learning algorithms to automatically process NCCT brain image data to provide an output ASPECTS score based on the Alberta Stroke Program Early CT Score (ASPECTS) guidelines. The post-processing image results and ASPECTS score are identified based on regional imaging features and overlayed onto brain scan images. e-ASPECTS provides an automatic ASPECTS score based on the input CT data for the physician. The score includes which ASPECTS regions are identified based on regional imaging features derived from NCCT brain image data. The results are generated based on the Alberta Stroke Program Early CT Score (ASPECTS) guidelines and provided to the clinician for review and verification. At the discretion of the clinician, the scores may be adjusted based on the clinician's judgment. Brainomix 360 e-ASPECTS can connect with other DICOM-compliant devices, for example to transfer NCCT scans from a Picture Archiving and Communication System (PACS) to Brainomix 360 e-ASPECTS software for processing. Results and images can be sent to a PACS via DICOM transfer and can be viewed on a PACS workstation or via a web user interface on any machine contained and accessed within a hospital network and firewall and with a connection to the Brainomix 360 e-ASPECTS software (e.g. a LAN connection). Brainomix 360 e-ASPECTS notification capabilities enable clinicians to preview images through a mobile application or via e-mail. Brainomix 360 e-ASPECTS email notification capabilities enable clinicians to preview images via e-mail notification with result image attachments. Images that are previewed via e-mail are compressed, are for informational purposes only, and not intended for diagnostic use beyond notification. Brainomix 360 e-ASPECTS is not intended for mobile diagnostic use. 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 e-ASPECTS provides an automated workflow which will automatically process image data received by the system in accordance with pre-configured user DICOM routing preferences. Once received, image processing is automatically applied. Once any image processing has been completed, notifications are sent to pre-configured users to inform that the image processing results are ready. Users can then access and review the results and images via the web user interface case viewer or PACS viewer. The core of e-ASPECTS algorithm (excluding image loading or result output format) can be summarised in the following 3 key steps of the processing pipeline: - Pre-processing: brain extraction from the three dimensional (3D) non-enhanced contrast CT head dataset and its reorientation/normalization by 3D spatial registration to a standard template space. - Delineation of the 20 (10 for each cerebral hemisphere) pre-defined ASPECTS regions of interest on the normalized 3D image. - Image feature extraction and heatmap generation which consists of the computation of numerical values characterizing brain tissue, apply a trained predictive model to those features and generate a 3D heatmap from the models output for highlighting regions contributing towards the ASPECTS score. The Brainomix 360 e-ASPECTS module is made available to the user through the Brainomix 360 platform. The Brainomix 360 platform is a central control unit which coordinates the execution image processing modules which support various analysis methods used in clinical practice today: - Brainomix 360 e-ASPECTS (K221564) (predicate device) - Brainomix 360 e-CTA (K192692) - Brainomix 360 e-CTP (K223555) - Brainomix 360 e-MRI (K231656) - Brainomix 360 Triage ICH (K231195) - Brainomix 360 Triage LVO (K231837) - Brainomix 360 Triage Stroke (K232496)

Brainomix 360 e-CTA 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 standard "off the-shelf" hardware (physical or virtualized) and can be used to perform image viewing, processing, and analysis of images. Data and images are acquired through DICOM compliant imaging devices. Brainomix 360 e-CTA provides viewing and analysis capabilities for imaging datasets acquired with CTA (CT Angiography). Brainomix 360 e-CTA is not intended for mobile diagnostic use. Brainomix 360 e-CTA vessel density asymmetry ratio applies only to the MCA region.

Brainomix 360 e-CTA is a medical image visualization and processing software package compliant with the DICOM standard and running on an off-the-shelf physical or virtual server. Brainomix 360 e-CTA allows for the visualization, analysis and post-processing of DICOM compliant CTA images which, when interpreted by a trained physician or medical technician, may yield information useful in clinical decision making. Brainomix 360 e-CTA provides a wide range of basic image viewing, processing and manipulation functions, through multiple output formats. Functionality includes image registration and visualization of large cerebral vessels to provide an analysis of hemispheric difference via contralateral comparison (displayed as a relative percentage). Brainomix 360 e-CTA processes the images using Al/ML algorithms where the input channels will help the software distinguish bone from vessels and reduce image grain. Brainomix 360 e-CTA automatically provides a colored overlay to provide a visual reference of the MCA hemisphere of the brain with lower vessel density, and corresponding contrast intensity measurements and estimated phase. Brainomix 360 e-CTA can connect with other DICOM-compliant devices, for example to transfer CTA scans from a Picture Archiving and Communication System (PACS) to Brainomix 360 e-CTA software for processing. Results and images can be sent to a PACS via DICOM transfer and can be viewed on a PACS workstation or via a web user interface on any machine and accessed within a hospital network and firewall and with a connection to the Brainomix 360 e-CTA software (e.g. a LAN connection). Brainomix 360 e-CTA notification capabilities enable clinicians to preview images via e-mail notification with result image attachments. Images that are previewed via e-mail are compressed, are for informational purposes only, and not intended for diagnostic use beyond notification. Brainomix 360 e-CTA is not intended for mobile diagnostic use. 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.

The e-Lung software provides reproducible CT values for pulmonary tissue, which is essential for providing quantitative support in the examination of radiological findings. These radiological findings can then be evaluated by the physician in conjunction with a range of ancillary information to form a potential diagnosis or list of likely diagnoses. The e-Lung software package is intended to be a workflow enhancement and for the assessment of CT thoracic datasets. e-Lung can be used to support the physician when examining the pulmonary and thoracic tissue (i.e. lung parenchyma) in CT thoracic datasets. 3D segmentation, volumetric measurements, density evaluations, and reporting tools are combined with a dedicated workflow.

Brainomix 360 e-Lung is a software package compliant with the DICOM standard and running on an off-the-shelf physical or virtual server. e-Lung is a CT processing module which operates within the integrated Brainomix 360 platform. Brainomix 360 e-Lung is a stand-alone software device which uses a set of image processing algorithms to perform evaluation (3D segmentation and isolation of sub-compartments, volumetric measurements, and density evaluations), editing, and reporting tools which are combined with a dedicated workflow. e-Lung can be used to support the physician in the examination of radiological findings that may be indicative of chest diseases e.g. when examining the pulmonary and thoracic tissue (i.e. lung parenchyma) in CT thoracic datasets. These radiological findings can then be evaluated by the physician in conjunction with a range of ancillary information to form a potential diagnosis or list of likely diagnoses. e-Lung is designed to analyze pulmonary CT slice data and display analysis results. Each voxel of the scan is measured by Hounsfield units (HU), a measurement of x-ray attenuation that is applied to each volume element in three dimensional space. The HU are utilized to distinguish between air, water, tissue and bone, such distinction is common in the industry. e-Lung provides computed tomography (CT) viewing, and parenchymal density analysis in one application. e-Lung provides quantitative measurements and tabulates quantitative properties. e-Lung focuses on what is visible to the eye and applies volumetric methods that might otherwise be too time consuming to use. The software does not perform any function which cannot be accomplished by a trained user utilizing manual tracing methods; the software does not reconstruct a 3D rendering image of the lung; the intent of the software is to enhance the workflow by saving time and automating potential error prone manual tasks. e-Lung has functions for loading, and saving datasets, and will generate screen displays, computations and aggregate statistics. e-Lung data output may be exported to a CSV, Excel or PDF file.

Brainomix 360 Triage Stroke is a radiological computer aided triage and notification software indicated for use in the analysis of non-contrast head CT (NCCT) images to assist hospital networks and trained clinicians in workflow triage by flagging and communicating suspected positive findings of head NCCT images for large vessel occlusion (LVO) of the intracranial ICA and M1 and intracranial hemorrhage (ICH). Specifically, the device is intended to be used for the trage of images acquired from adult patients in the acute setting, within 24 hours of the acute symptoms, or where this is unclear, since last known well (LKW) time. It is not intended to detect isolated subarachnoid hemorrhage and symmetrical bilateral MCA occlusions. Brainomix 360 Triage Stroke uses an artificial intelligence algorithm to analyze images and highlight cases with detected NCCT LVO or ICH on the Brainomix server on premise or in the cloud in parallel to the ongoing standard of care image interpretation. The user is presented with notifications for cases with suspected LVO or ICH findings via a web user interface or mobile applications include compressed preview images that are meant for informational purposes only and are not intended for diagnostic use beyond notification. The device does not alter the original mage, and it is not intended to be used as a primary diagnostic device. The results of Brainomix 360 Triage Stroke are intended to be used in conjunction with other patient information and based on professional judgment to assist with triage/prioritization of medical images. Notified clinicians are ultimately responsible for reviewing full images per the standard of care.

Brainomix 360 Triage Stroke is a radiological computer aided triage and notification software package compliant with the DICOM standard and running on an off-the-shelf physical or virtual server. The Triage Stroke module is a non-contrast CT processing module which operates within the integrated Brainomix 360 Platform to provide triage and notification of suspected large vessel occlusion (LVO) and intracranial hemorrhage (ICH). Brainomix 360 Triage Stroke is a stand-alone software device which uses machine learning algorithms that uses advanced non adaptive imaging artificial intelligence, and large data analytics to automatically identify suspected LVO and ICH on non-contrast CT (NCCT) imaging acquired from adult patients in the acute setting, within 24 hours of the acute symptoms, or where this is unclear, since last known well (LKW) time. The output of the module is a priority notification to clinicians indicating the suspicion of LVO or ICH based on positive findings. Specifically, Brainomix 360 Triage Stroke's ICH analysis is optimized to identify findings of hyperdense volume in the parenchyma typically associated with acute intracranial hemorrhage; and the NCCT LVO suspicion uses the combined analysis of the ASPECTS and hyperdense vessel sign (HDVS) algorithms. It is not intended to detect isolated subarachnoid hemorrhage and symmetrical bilateral MCA occlusions. The Triage Stroke module uses the basic services supplied by the Brainomix 360 Platform including DICOM processing, job management, imaging module execution and imaging output including the notification and compressed image.

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 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 Triaqe LVO is intended to analyze terminal ICA and MCA-M1 vessels for LVOs. lmages 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.

Brainomix 360 Triage LVO is a radiological computer aided triage and notification (CADt) software package compliant with the DICOM standard and running on an off-the-shelf physical or virtual server. The Triage LVO module is a CTA processing module which operates within the integrated Brainomix 360 Platform to provide triage and notification of suspected LVO. Brainomix 360 Triage LVO is a stand-alone software device which uses machine learning algorithms that uses advanced non adaptive imaging algorithms, artificial intelligence, and large data analytics to automatically identify suspected LVO on CTA imaging in the acute setting. The output of the module is a priority notification to clinicians indicating the suspicion of LVO based on positive findings. Specifically, Brainomix 360 Triage LVO is optimized to evaluate occlusions of the intracranial internal carotid artery (ICA) and proximal middle cerebral artery (M1 segment). The Triage LVO module uses the basic services supplied by the Brainomix 360 Platform including DICOM processing, job management, imaging module execution and imaging output including the notification and compressed image. Brainomix 360 Triage LVO notification capabilities enable clinicians to review and preview images via mobile app notification. Alternatively, intended users can also access the notification (a "Suspected LVO" flag) and straightened images via the Brainomix 360 web user interface. Images that are previewed via mobile app are compressed, are for preview informational purposes only, and not intended for diagnostic use beyond notification. The device is intended for use as an additional tool for assisting study triage within existing patient pathways. It does not replace any part of the current standard of care. It is designed to assist in prioritization of studies for reading within a worklist, in addition to any other pre-existing formal or informal methods of study prioritization in place. Specifically, it does not remove cases from a reading queue and operates in parallel to the standard of care. This device is not intended to replace the usual methods of communication and transfer of information in the current standard of care. Brainomix 360 Triage LVO notification capabilities enable clinicians to preview compressed and informational images through via mobile application with preview of unprocessed image attachments. Alternatively, the user may review unprocessed images via web user interface on a radiology workstation.

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.

Brainomix 360 e-MRI software allows for visualization of DICOM compliant MRI (Mage Resonance) digital images. The software has been designed to run with off-the-shelf physical or virtual servers and provides for viewing, quantification, analysis, and reporting, as an aid to physician diagnosis. The software system consists of platform functionality and the e-MRI processing module. It provides both analysis and viewing capabilities for functional and dynamic imaging datasets acquired with MR including Diffusion Weighted Imaging (DWI) and Dynamic Susceptibility Contrast (DSC), which is the term used in the Brainomix 360 e-MRI software for perfusion-weighted imaging technique. The DWI capabilities are for visualization of local water diffusion properties from the analysis of diffusion-weighted MR data. The DSC capabilities are for the characterization of perfusion parameters in the injection of a contrast bolus, and visualization of these parameters. e-MRI provides a wide range of basic image viewing, processing and manipulation functions, through multiple output formats. The Brainomix 360 platform has been designed to connect with other DICOM-compliant devices. This functionality enables the transfer of MRI scans from a Picture Archiving and Communication System (PACS) to Brainomix 360 e-MRI software for processing.

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 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. Limitations: · Brainomix 360 Triage ICH is not intended for mobile diagnostic use. Images viewed on a mobile platform are preview images and not for diagnostic interpretation. - · Brainomix 360 Triage ICH has been validated and is intended to be used on GE and Philips scanners. - · Brainomix 360 Triage ICH is not intended to detect isolated subarachnoid hemorrhage. - · Brainomix 360 Triage ICH is not intended to be used on patients with recent (within 6 weeks) neurosurgery or endovascular neurointervention or recent (within 4 weeks) previous diagnosis of intracranial hemorrhage. Contraindications: Brainomix 360 Triage ICH is not suitable for use with scan data containing image features associated with: - · tumors or abscesses - · coils, shunts, embolization or movement artefacts Brainomix 360 Triage ICH is not intended to be used for analyzing CT images in intracranial vascular pathologies such as arterial aneurysms, arteriovenous malformations or venous thrombosis.

Brainomix 360 Triage ICH is a radiological computer aided triage and notification software package compliant with the DICOM standard and running on an off-the-shelf physical or virtual server. The Triage ICH module is a non-contrast CT processing module which operates within the integrated Brainomix 360 Platform to provide triage and notification of suspected intracranial hemorrhage (ICH). Brainomix 360 Triage ICH is a stand-alone software device which uses machine learning algorithms that uses advanced non adaptive imaging algorithms, artificial intelligence, and large data analytics to automatically identify suspected ICH on non-contrast CT (NCCT) imaging 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. The module is a priority notification to clinicians indicating the suspicion of ICH based on positive findings. Specifically, Brainomix 360 Triage ICH is optimized to detect and evaluate hyperdense volume in the parenchyma typically associated with acute intracranial hemorrhage (ICH). The Triage ICH module uses the basic services supplied by the Brainomix 360 Platform including DICOM processing, job management, imaging module execution and imaging output including the notification and compressed image. Brainomix 360 Triage ICH notification capabilities enable clinicians to review images via mobile app notification. Alternatively, intended users can also access the notification (a "Suspected hemorrhage" flag) and straightened images via the Brainomix 360 web user interface. Images that are previewed via mobile app are compressed, are for preview informational purposes only, and not intended for diagnostic use beyond notification. The device is intended for use as an additional tool for assisting study triage within existing pathways. It does not replace any part of the current standard of care. It is designed to assist in prioritization of studies for reading within a worklist, in addition to any other pre-existing formal methods of study prioritization in place. Specifically, it does not remove cases from a reading queue and operates in parallel to the standard of care. This device is not intended to replace the usual methods of communication and transfer of information in the current standard of care.

Brainomix 360 e-CTP 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-CTP provides viewing and analysis capabilities for imaging datasets acquired with CT Perfusion. The CT Perfusion 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.

Brainomix 360 e-CTP software allows for visualization of DICOM compliant CT (Computed Tomography) digital images. The software has been designed to run with off-the-shelf physical or virtual servers and provides for viewing, quantification, analysis, and reporting, as an aid to physician diagnosis. The software consists of one processing module: - 1. e-CTP Module- provides both analysis and viewing capabilities for brain CT Perfusion datasets for characterization of perfusion parameters in the image following the injection of a contrast bolus, and visualization of these parameters.

Brainomix 360 e-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 uses an Atlas to segment and analyze ASPECTS regions. Brainomix 360 e-ASPECTS extracts image data from individual voxels in the image to provide analysis and computer and relates the analysis to the atlas defined ASPECTS regions. The imaging features are then synthesized by an artificial intelligence algorithm into a single ASPECTS (Alberta Stroke Program Early CT) Score. Brainomix 360 e-ASPECTS is indicated for evaluation of patients presenting for diagnostic imaging workup with known MCA or ICA occlusion, for evaluation of extent of disease. Extent of disease refers to the number of ASPECTS regions affected which is reflected in the total score. Brainomix 360 e-ASPECTS provides information that may be useful in the characterization of ischemic brain tissue injury during image interpretation (within 6 hours from time last known well). Brainomix 360 e-ASPECTS provides a comparative analysis to the ASPECTS standard of care radiologist assessment by providing highlighted ASPECTS regions and an automated editable ASPECTS score for clinician review. Brainomix 360 e-ASPECTS additionally provides a visualization of the voxels contributing to the automated ASPECTS score and the voxels excluded from the automated ASPECTS score. Limitations: 1. Brainomix 360 e-ASPECTS is not intended for primary interpretation of CT images. It is used to assist physician evaluation. 2. Brainomix 360 e-ASPECTS has been validated in patients with known MCA or ICA occlusion prior to ASPECTS scoring. 3. Brainomix 360 e-ASPECTS is not suitable for use on brain scans displaying neurological pathologies other than acute stroke, such as tumours or abscesses, haemorrhagic transformation and hematoma. 4. Use of Brainomix 360 e-ASPECTS Module in clinical settings other than brain ischemia within 6 hours from time last known well, caused by known ICA or MCA occlusions has not been tested. 5. Brainomix 360 e-ASPECTS has only been validated and is intended to be used in patient populations aged over 21. 6. Brainomix 360 e-ASPECTS has been validated and is intended to be used on Siemens Somatom Definition scanners. 7. Brainomix 360 e-ASPECTS is not intended for mobile diagnostic use. Images viewed on a mobile platform are compressed preview images and not for diagnostic interpretation. Contraindications/Exclusions/Cautions: · Patient motion: Excessive patient motion leading to artifacts that make the scan technically inadequate. - · Haemorrhagic Transformation, Hematoma.

Brainomix 360 e-ASPECTS is a stand-alone software device which uses machine learning algorithms to automatically process NCCT (Non-contrast CT scans) brain image data to provide an output ASPECTS score based on the Alberta Stroke Program Early CT Score (ASPECTS) guidelines. The post-processing image results and ASPECTS score are identified based on regional imaging features and overlayed onto brain scan images. e-ASPECTS provides an automatic ASPECTS score based on the input CT data for the physician. The score includes which ASPECTS regions are identified based on regional imaging features derived from non-contrast computed tomography (NCCT) brain image data. The results are generated based on the Alberta Stroke Program Early CT Score (ASPECTS) guidelines and provided to the clinician for review and verification. At the discretion of the clinician, the scores may be adjusted based on the clinician's judgment. Brainomix 360 e-ASPECTS can connect with other DICOM-compliant devices, for example to transfer NCCT scans from a Picture Archiving and Communication System (PACS) to Brainomix 360 e-ASPECTS software for processing. Results and images can be sent to a PACS via DICOM transfer and can be viewed on a PACS workstation or via a web user interface on any machine contained and accessed within a hospital network and firewall and with a connection to the Brainomix 360° e-ASPECTS software (e.g. a LAN connection) Brainomix 360 e-ASPECTS notification capabilities enable clinicians to preview images through via email notification with result image attachments. lmages that are previewed via e-mail are compressed, are for preview purposes only, and not intended for diagnostic use beyond notification. Brainomix 360 e-ASPECTS is not intended for mobile diagnostic use. 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 e-ASPECTS provides an automated workflow which will automatically process image data received by the system in accordance with pre-configured user DICOM routing preferences. Once received, image processing is automatically applied. Once any image processing has completed, notifications are sent to pre-configured users to inform that the image processing results are ready. User can then access and review the results and images via the Web User Interface case viewer or PACS viewer. Brainomix 360 e-ASPECTS principal workflow for NCCT includes the following key steps: - NCCT Image Loading. - . Automated image analysis and processing to identify and visualize the voxels which have been included in the ASPECTS score and the voxels which have been excluded from the ASPECTS score (Also referred to as a 'heat map'). - Automated image analysis and processing to register the subject image to an atlas to segment and highlight ASPECTS regions and to display whether or not each region is qualified as contributing to the ASPECTS score. - . Notifications and alerts to users. - Generation of a summary results report. - Presentation of results for review and analysis by users. Once the physician has been notified of availability of the ASPECTS score, the system requires that the physician confirms that the case in question is for an ICA occlusion. The ASPECTS results, including the ASPECTS score, indication of affected side, affected ASPECTS regions and voxel-wise analysis (shown as a heatmap of voxels 'contributing to e-ASPECTS score' and a heat map of voxels 'excluded from e-ASPECTS score') can be exported as a report and/or sent to the Picture Archiving and Communications System (PACS).