https://www.medpagetoday.com/neurology/strokes/71174?xid=nl_mpt_DHE_2018-02-15&eun=g424561d0r&pos=0&utm_source=Sailthru&
- February 14, 2018
Viz.AI Contact software that provides artificial intelligence-assisted stroke detection for CT scans and automatically notifies neurovascular specialists by text message got U.S. marketing approval from the FDA, the agency
Giving the alert on suspected large vessel infarcts early -- at the time a first-line provider is conducting a standard review of the images -- theoretically gets the specialist involved faster than waiting for a radiologist to complete his or her review of the scans.
The platform is designed to analyze all stroke-protocol CT angiography images of the brain and works with any standard commercial CT scanner. "The system is designed for hospitals to push DICOM [Digital Imaging and Communications in Medicine] imaging data to the cloud where the Viz.AI deep learning artificial intelligence resides," a representative of the company told MedPage Today.
Nonetheless, the application is limited to the analysis of CT scans and should not be used as a replacement of a full patient evaluation or solely relied upon to make or confirm a diagnosis, according to the FDA statement.
Approval for Viz.AI Contact was supported by the ALADIN study wherein the application matched two neuro-radiologists in performance. ALADIN was presented at the International Stroke Conference this year, with an abstract citing sensitivity of 0.97 and specificity of 0.52, with a positive predictive value of 0.74, negative predictive value of 0.91, and overall accuracy of 0.78 in internal carotid artery terminus, middle cerebral artery-M1 large vessel occlusions versus more distal occlusions or no large vessel occlusion.
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