SAN FRANCISCO – The U.S. Food and Drug Administration has permitted marketing of the Viz.AI contact app, a type of clinical decision support software designed to analyze computed tomography (CT) results that could notify providers of a potential stroke in their patients.
“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,” said Dr. Chris Mansi, CEO of Viz.ai, in a statement. “We are thrilled to bring artificial intelligence to health care in a way that works alongside physicians and helps get the right patient to the right doctor at the right time.”
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. 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 app 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 app 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. 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 marketing authorization by demonstrating substantial equivalence to a predicate device.