The FDA cleared Viz.ai’s clinical support tool on Feb. 13, allowing the software that alerts clinicians to the possibility of a stroke to be marketed in the United States.

The product uses an algorithm to analyze CT images of the brain and send text notifications to neurovascular specialists if a large vessel blockage is present, according to the FDA’s news release. The notification would be sent at the same time a radiologist is manually reviewing the images, potentially leading to faster treatment.

Timely treatment is critical in stroke, the fifth-leading cause of death in the U.S. and a major cause of disability. About 795,000 Americans have a stroke each year, according to the Centers for Disease Control and Prevention (CDC).

“Strokes can cause serious and irreversible damage to patients,” said Robert Ochs, PhD, with the FDA’s Center for Devices and Radiological Health. “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.”

The FDA said it is creating a regulatory framework for artificial intelligence (AI) to encourage developers to create these products to help providers with challenging diagnoses and treatments.

In a 300-patient study, the Viz.ai platform identified large vessel occlusions (LVOs) with 90 percent sensitivity and specificity and demonstrated a median scan to notification time of less than six minutes. Using the software resulted in faster notification of the specialist 95 percent of the time, with an average savings of 52 minutes, according the company’s press release. The tool received CE mark approval in January.

"The Viz.ai LVO Stroke Platform is the first example of applied artificial intelligence software that seeks to augment the diagnostic and treatment pathway of critically unwell stroke patients," Chris Mansi, MD, a neurosurgeon and Viz.ai’s president and CEO, said in the release. "We are thrilled to bring artificial intelligence to healthcare in a way that works alongside physicians and helps get the right patient to the right doctor at the right time."