The US Food and Drug Administration (FDA) has cleared for marketing a clinical decision support software that may help get stroke patients appropriate treatment more quickly.
The Contact application from Viz.AI is a computer-aided triage software that uses an artificial intelligence (AI) algorithm to analyze computed tomography (CT) images for indicators associated with a stroke, the FDA explained.
“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,” 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, said in a statement.
The Viz.AI Contact application analyzes brain CT images and sends a text notification to a neurovascular specialist if a suspected large-vessel occlusion is identified. The algorithm automatically notifies the specialist at 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 FDA noted.
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 FDA said.
“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,” they cautioned.
In clearing the Viz.AI Contact application, the FDA reviewed a retrospective study of 300 CT images that assessed the independent performance of the image analysis algorithm and notification functionality of the application against the performance of two trained neuroradiologists for the detection of large-vessel occlusions 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 FDA said.
Mounting evidence suggests that AI algorithms can help providers identify the most appropriate treatment plan for a patient’s disease or condition. The FDA is 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 FDA reviewed the Viz.AI system through its “de novo” premarket review pathway, which addresses low- to moderate-risk medical devices for which there is no already-marketed device to use for comparison. Now, future similar computer-aided triage software devices will be able to go through the 510(k) process to demonstrate substantial equivalence to this novel product.
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