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.
Клиническая обстановка
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.
Инструменты и поставщики
Viz.ai ContaCT
Что сообщил источник
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.
Источник
U.S. FDA announcement, 13 February 2018 · 13 февр. 2018 г. · Год 2018
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LumineticsCore (IDx-DR) · Digital Diagnostics · Topcon NW400
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