The US Food and Drug Administration (FDA) has granted permission to market VizAI’s clinical decision support software, called Contact application, for the identification and notification of a potential stroke.
The computer-aided triage software leverages an artificial intelligence algorithm to examine computed tomography (CT) images / results of the brain for the presence of any indicators related to the condition.
The software sends alerts to the patient’s provider and a neurovascular specialist when a suspected large vessel blockage is detected.
Intended to involve the specialist sooner than the usual standard of care, the notifications are sent to a mobile device, while the specialist has to review the images on a clinical workstation.
FDA Office of In Vitro Diagnostics and Radiological Health acting deputy director for radiological health Robert Ochs said: “Strokes can cause serious and irreversible damage to patients.
“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.”
The VizAI Contact application is indicated for use by neurovascular specialists to analyse imaging data, but cannot be used for diagnosis confirmation.
VizAI validated the software in a retrospective study with 300 CT images designed to examine the independent performance of the algorithm and its notification functionality for identifying large vessel blockages in the brain, compared to two trained neuro-radiologists.
Another study was performed to collect real-world evidence demonstrating the capability of the application to alert a neurovascular specialist sooner in case of a suspected blockage.