FDA permits marketing of clinical decision support software for alerting providers of a potential stroke in patients Today, the U.S. Food and Drug Administration permitted marketing of the Viz.AI Contact application, a type of clinical decision support software designed to analyze computed tomography (CT) results that may notify 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.

About 795,000 people in the U.S. have a stroke each year. “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,” said 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.

The Viz.AI Contact application is a computer-aided triage software that uses an artificial intelligence algorithm to analyze images for indicators associated with a stroke. Artificial intelligence algorithms are a type of clinical decision support software that can assist providers in identifying the most appropriate treatment plan for a patient’s disease or condition. Read more from fda.gov…

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