Parallel notification of a suspected large-vessel occlusion
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Viz.ai ContaCT analyzes brain CT angiography and can text a neurovascular specialist when it suspects a large-vessel occlusion, in parallel with the usual read. FDA permitted marketing in 2018 as notification software. The specialist still reviews full images on a diagnostic workstation. The product is not a diagnosis and not a treatment decision.
Cenário clínico
Emergency stroke imaging, for adults who already have a CT angiogram as part of a stroke workup, inside a hospital network that has a specialist on call.
Ferramentas e fornecedores
Viz.ai ContaCT
O que a fonte relatou
FDA described a retrospective set of 300 CT angiograms reviewed against neuro-radiologists, plus real-world evidence aimed at earlier specialist notification. This card does not restate a sensitivity figure. The labeled limit is notification, not a stand-alone read.
Fonte
U.S. FDA announcement, 13 February 2018 · 13 de fev. de 2018 · Ano 2018
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IDx-DR, now marketed as LumineticsCore by Digital Diagnostics, was authorized to screen adults with diabetes for more-than-mild diabetic retinopathy without an eye specialist reading the photo first. A primary care team captures images on a specified retinal camera and the software returns a refer-or-rescreen result. It is not a complete eye examination. Pregnancy and several existing retinal conditions sit outside the labeled use.
LumineticsCore (IDx-DR) · Digital Diagnostics · Topcon NW400
The MASAI trial in Sweden randomly assigned screening mammograms to AI-supported reading or standard double reading without AI. Transpara scored each exam and routed lower scores to a single reader and the highest score to double reading, with detection marks available on higher-risk exams. This card quotes the prespecified interim safety analysis, not a claim that every screening program should switch.