FDA clears CDS solution software for CT stroke analysis

By Staff News Brief

Artificial intelligence-based clinical decision support (CDS) solution software for stroke diagnosis from computed tomography (CT) images from Viz.AI has received market clearance from the U.S. Food and Drug Administration (FDA). The Viz.AI Contact application is designed to analyze CT images of the brain and to send a text notification to a neurovascular specialist if a suspected large vessel occlusion (LVO) has been identified by a radiologist.

The application is a computer-aided triage software that uses an artificial intelligence algorithm to analyze images for indicators associated with a stroke. The software will automatically notify a designated neurovascular specialist by text to a smartphone or tablet as a radiologist is interpreting the images. The application is limited to analysis of imaging data, but the company referenced a retrospective clinical study of 300 CT images submitted to the FDA which showed that Viz.AI Contact’s automatic notifications to a neurovascular special saved an average of 52 minutes.

The Viz.AI Contact application was reviewed through the De Novo premarket review pathway. The San Francisco-headquartered company stated that this approval paves the way for future computer-aided triage software devices.

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FDA clears CDS solution software for CT stroke analysis.  Appl Radiol. 

By Staff News Brief| March 05, 2018

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