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New Stroke-Detecting Software Gets FDA Nod
The FDA has approved marketing of the Viz.AI Contact application, a type of clinical decision support software designed to analyze CT results that may notify providers of a potential stroke in their patients. According to the Centers for Disease Control and Prevention, stroke is the fifth leading cause of death in the United States and is a major cause of serious disability for adults. About 795,000 people in the United States have a stroke each year.
“Strokes can cause serious and irreversible damage to patients,” says Robert Ochs, PhD, acting deputy director for radiological health at the Office of In Vitro Diagnostics and Radiological Health in 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 Viz.AI Contact application is a computer-aided triage software that uses an AI algorithm to analyze images for indicators associated with a stroke. AI 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 while the first-line provider is conducting a standard review of the images, potentially involving the specialist sooner than the usual standard of care (ie, 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.
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. 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.
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. The application was measured against the performance of two trained neuroradiologists 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.
The Viz.AI Contact application was reviewed through the De Novo premarket review pathway. This is 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. 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 process, whereby devices can obtain 510(k) marketing authorization by demonstrating substantial equivalence to a predicate device.
— Source: FDA
