The US Food and Drug Administration (FDA) has permitted marketing of the VizAI Contact application, described as a type of decision support software designed to analyzed computed tomography results that may notify providers of a potential stroke in their patients.
The VizAI Contact application is a computer-aided triage software that uses an artificial intelligence algorithm to analyze images for indicators associated with a stroke. It 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 smartphone or tablet, but the specialist still needs to review the images on a clinical workstation, explains a media release from the FDA.
“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,” said Robert Ochs, PhD, acting deputy director for radiological health, Office of In Vitro Diagnostics and Radiological Health in the FDA’s Center for Devices and Radiological Health, in the release.
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 full patient evaluation or solely relied upon to make or confirm diagnosis, the FDA cautions.
[Source(s): US Food and Drug Administration, PR Newswire]
