Viz™ LVO

Viz 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.

Viz LVO uses an artificial intelligence algorithm to analyze images for findings suggestive of a pre-specified 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 has been identified and recommends review of those images. Images can be previewed through a mobile application. Viz LVO is intended to analyze terminal ICA and MCA-M1 vessels for LVO.

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. Viz 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.

Viz™ ICH

Viz 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.

Viz 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 analyzes non-contrast CT images of the brain acquired in the acute setting, and sends notifications to a neurovascular or neurosurgical 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 may be 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. Viz 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.

Viz™ CTP

Viz CTP is an image processing software package for use 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 processing, analysis, and communication of computed tomography (CT) perfusion scans of the brain. Data and images are acquired through DICOM-compliant imaging devices.

Viz CTP provides both analysis and communication capabilities for dynamic imaging datasets that are acquired with CT Perfusion imaging protocols. Analysis includes calculation of parameters related to tissue flow (perfusion) and tissue blood volume. Results of image processing, which include CT perfusion parameter maps from a raw CTP scan are exported in standard DICOM format and may be viewed on existing radiological imaging viewers.

Viz™ ANEURYSM

Viz ANEURYSM (Viz ANX) 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 aneurysms during routine patient care.

Viz ANEURYSM uses an artificial intelligence algorithm to analyze images and highlight studies with suspected 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 standalone application. When viewed through the standalone application the images are for informational purposes only and not for diagnostic use. The results of Viz ANEURYSM, in conjunction with other clinical information and professional judgment, are to be used to assist with triage/prioritization of medical images. Radiologists who read the original medical images are responsible for the diagnostic decision. Viz ANEURYSM 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.

Viz ANEURYSM is limited to detecting aneurysms at least 4mm in diameter.

Viz™ SDH

Viz SDH 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.

Viz SDH 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 non-contrast CT images of the head for subdural hemorrhage and sends notifications to a neurovascular or neurosurgical specialist that a suspected subdural 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 may be 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. Viz SDH 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.

Viz™ RV/LV

The Viz RV/LV Software device is designed to measure the maximal diameters of the right and left ventricles of the heart from a volumetric CTPA acquisition and report the ratio of those measurements. Viz RV/LV analyzes cases using an artificial intelligence algorithm to identify the location and measurements of the ventricles. The Viz RV/LV software provides the user with annotated images showing ventricular measurements. Its results are not intended to be used on a stand-alone basis for clinical decision-making or otherwise preclude clinical assessment of CTPA cases.