FDA permits marketing of software to alert providers of potential strokes in patients

Editor's Note

The Food & Drug Administration (FDA) on February 13 announced that it is permitting the marketing of clinical decision support software that alerts providers to potential strokes in their patients.

The Viz.AI Contact application is designed to analyze computed tomography images of the brain and send a text notification to a neurovascular specialist if a suspected large vessel blockage is identified.

The algorithm will automatically notify the specialist during the same time the first-line provider is conducting a standard review of the images, involving the specialist sooner than the usual standard of care.

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.

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