U.S Food and Drug Administration paved way for the marketing of the Viz.AI Contact application which is a type of clinical decision support software designed to interpret computed tomography results that may intimate providers of a potential stroke in their patients.
A stroke is a serious medical condition that requires emergency care and can cause lasting brain damage, long-term disability or even death. A stroke occurs if the flow of oxygen-rich blood to a portion of the brain is blocked, also known as an occlusion. According to the Centers for Disease Control and Prevention, stroke is the fifth leading cause of death in the U.S. and is a major cause of serious disability for adults.
Robert Ochs, Ph.D., acting deputy director for radiological health, Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health 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 Viz.AI Contact application is designed to analyze CT images of the brain and send a text notification to a neurovascular specialist if a suspected large vessel blockage has been identified. The algorithm will automatically notify the specialist during the same time the first-line provider is conducting a standard review of the images, potentially involving the specialist sooner than the usual standard of care in which patients wait for a radiologist to review CT images and notify a neurovascular specialist. The Viz.AI Contact application was reviewed through the De Novo premarket review pathway, a regulatory pathway for some new types of medical devices that are low to moderate risk and have no legally marketed predicate device to base a determination of substantial equivalence.