The Food and Drug Administration (FDA) has granted marketing clearance of the Viz.AI Contact application, a new clinical decision support software that analyzes computed tomography (CT) results to alert providers of a potential stroke in their patients. 

The application is a computer-aided triage software that utilizes an artificial intelligence (AI) algorithm to analyze CT images for specific stroke-associated indicators. Once the brain CT images are analyzed, a text notification is sent to a neurovascular specialist if a large vessel blockage has been detected. The specialist is automatically notified while the first-line provider is reviewing the images, allowing for earlier specialist involvement compared to the usual standard of care. The specialist can receive the text notification via a mobile device but will need to review the images on a clinical workstation. 

The FDA clearance was supported by retrospective study data of 300 CT images that evaluated the independent performance of the algorithm and notification functionality of the application vs the performance of 2 trained neuro-radiologists for detecting large blockages in the brain. Clinical and real-world data demonstrated that the Viz.AI Contact application could inform a neurovascular specialist sooner in cases where a blockage was suspected. 

The Viz.AI Contact application should be used by specialists such as vascular neurologists, neuro-interventional specialists or other professionals with similar background. The application is not intended to replace a full patient evaluation nor should it be solely used to make or confirm a diagnosis. 

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“The software device could benefit patients by notifying a specialist earlier thereby decreasing the time to treatment. Faster treatment may lessen the extent or progression of a stroke,” said Robert Ochs, PhD, acting deputy director for radiological health, Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health.

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