February 12, 2018
FDA Approves Marketing of Viz.ai's Stroke Identification Software Application
February 13, 2018—The US Food and Drug Administration (FDA) announced that it has permitted marketing of Viz.ai’s Contact application, a clinical decision support software designed to analyze CT results that may notify providers of a potential stroke in their patients.
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. This algorithm may assist providers in identifying the most appropriate treatment plan for a patient’s disease or condition.
According to the FDA’s announcement, the application is designed to analyze CT images of the brain and send a text notification to a neurovascular specialist if a suspected large vessel occlusion has been identified. The algorithm automatically notifies the specialist during the same time that 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 smartphone or tablet, but the specialist still needs to review the images on a clinical workstation.
In the FDA’s announcement, Robert Ochs, PhD, commented, “Strokes can cause serious and irreversible damage to patients. 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.” Dr. Ochs is acting Deputy Director for Radiological Health, Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health.
The Viz.ai Contact application is intended to be used by neurovascular specialists, such as vascular neurologists, neurointerventional specialists, or other professionals with similar training, advised the FDA. The application is limited to analysis of imaging data and should not be used as a replacement for a full patient evaluation or solely relied upon to make or confirm a diagnosis.
To obtain FDA approval, 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 occlusions in the brain. The FDA explained in its announcement that real-world evidence was used in conjunction with a clinical study to demonstrate that the application could notify a neurovascular specialist sooner in cases where an occlusion was suspected.
The software was reviewed through the FDA’s de novo premarket review pathway, a regulatory pathway for some new types of medical devices that are low to moderate risk and have no legally marketed predicate device to base a determination of substantial equivalence.
The FDA is currently creating a regulatory framework for clinical decision support software that encourages developers to create, adapt, and expand the functionalities of their software to aid providers in diagnosing and treating diseases and conditions.