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FDA Permits Marketing of Stroke Alert Software

FDA news release; 2018 Feb 13

Publish date:: February 26, 2018

The US Food and Drug Administration has 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. In the US, Viz.AI is headquartered in San Francisco.

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.

The Viz.AI Contact application is intended to be used by neurovascular specialists, such as vascular neurologists, neuro-interventional specialists, or other professionals with similar training. The application is limited to analysis of imaging data and should not be used as a replacement of a full patient evaluation or solely relied upon to make or confirm a diagnosis.

Citation:

US Food and Drug Administration. FDA permits marketing of clinical decision support software for alerting providers of a potential stroke in patients. FDA Web site. February 13, 2018. https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm596575.htm. Accessed February 15, 2018.

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