FDA permits marketing of clinical decision support software for alerting providers of a potential stroke in patients
The U.S. Food and Drug Administration 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.
A stroke is a serious medical condition that requires emergency care and can cause lasting brain damage, long-term disability or even death. A stroke occurs if the flow of oxygen-rich blood to a portion of the brain is blocked, also known as an occlusion. According to the Centers for Disease Control and Prevention, stroke is the fifth leading cause of death in the U.S., and is a major cause of serious disability for adults. About 795,000 people in the U.S. have a stroke each year.
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 FDA is currently creating a regulatory framework for these products that encourages developers to create, adapt and expand the functionalities of their software to aid providers in diagnosing and treating diseases and conditions.
The Viz.AI Contact application is designed to analyze CT images of the brain and send a text notification to a neurovascular specialist if a suspected large vessel blockage has been identified. The algorithm will automatically notify the specialist during the same time the first-line provider is conducting a standard review of the images, potentially involving the specialist sooner than the usual standard of care in which patients wait for a radiologist to review CT images and notify a neurovascular specialist. The notification can be sent to a mobile device, such as a smart phone or tablet, but the specialist still needs to review the images on a clinical workstation.
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.
The company 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 neuro-radiologists for the detection of large vessel blockages in the brain. Real-world evidence was used with a clinical study to demonstrate that the application could notify a neurovascular specialist sooner in cases where a blockage was suspected.
