Health IT, Startups

FDA greenlights marketing of AI-enabled stroke analysis, alert for clinicians

Viz.AI's product uses a form of artificial intelligence to analyze computed tomography images of the brain to detect signs of a stroke.

The U.S. Food and Drug Administration approved the marketing of a clinical decision support tool designed to help neurologists more rapidly determine if a patient has experienced a stroke, according to a news release from the regulator.

Viz.AI‘s product uses a form of artificial intelligence to analyze computed tomography images of the brain to detect indicators associated with a stroke. Viz.AI’s Contact app is designed to send a text alert to a neurovascular specialist if it detects a suspected large vessel blockage, according to the FDA news release. The message is transmitted via a mobile device, but a specialist still needs to review the images on a clinical workstation.

The tool was approved in a De Novo pre-market review pathway, which is used for medical devices deemed to be low to moderate risk by the regulator and have no legally marketed predicate device to base a determination of substantial equivalence, according to the news release:

This action also creates a new regulatory classification, which means that subsequent computer-aided triage software devices with the same medical imaging intended use may go through the FDA’s premarket notification (510 (k)) process, whereby devices can obtain marketing authorization by demonstrating substantial equivalence to a predicate device.

Time is of the essence when it comes to diagnosing strokes, which are the fifth leading cause of death in the U.S. and affect 795,000 people each year. Strokes are also a significant contributor to disability for adults, according to data from the Centers for Disease Control and Prevention.

Viz.AI submitted a retrospective study which assessed the performance of the Viz.AI Contact image analysis and notification app in comparison with two trained neuro radiologists to analyze 300 CT images to detect large vessel blockages in the brain. Real-world evidence was used in a clinical study to demonstrate that the application could notify a neurovascular specialist sooner in cases where a blockage was suspected. The FDA used “real world evidence” to conclude that Viz.AI Contact could notify a neurovascular specialist sooner than physicians in cases where a blockage was suspected.

Artificial intelligence algorithms figure into the FDA’s pre-certification program, designed to streamline the regulation of certain health IT tools. The program is currently in the pilot stage.

Photo: ClarkandCompany, Getty Images

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