Viz.Ai Gets Marketing Approval from the FDA for Stroke-Stopping App

Viz.Ai has just received Food and Drug Administration (FDA) clearance to market its artificial intelligence application that can alert a neurovascular specialist if their patient is possibly suffering a stroke.

When the app detects large vessel blockage, it sends the physician a text message who can then review the patient’s brain images at their computer station. This alert system can expedite treatment procedures and potentially delay the stroke’s progression.

More young adults are being hospitalized for strokes. Although there has been an increase in stroke survival rates, as of 2013, stroke is the fifth leading cause of death in the United States. According to the Centers for Disease Control and Prevention, around 795,000 people die from a stroke in the U.S. every year.

Viz.Ai was approved through the FDA’s De Novo “premarket review pathway,” which regulates new medical devices for low to moderate risk patients. The FDA states that Viz.Ai isn’t intended to be a substitute for “a full patient evaluation or solely relied upon to make or confirm a diagnosis.”

According to the FDA, Viz.Ai “submitted a retrospective study of 300 CT images that assessed the independent performance of the image analysis algorithm and notification functionality of the Viz.Ai contact application against the performance of two trained neuroradiologists for the detection of large vessel blockages in the brain.”

This new detection technology could decrease the growing stroke rate in the U.S. “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, PhD, director of the Division of Radiological Health at the FDA.