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規制ニュース

Parallel notification of a suspected large-vessel occlusion

この言語の本文は未訳のため、英語で表示しています。

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.

臨床の場

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.

ツールとベンダー

  • Viz.ai ContaCT

出典が報告したこと

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.

出典

U.S. FDA announcement, 13 February 2018 · 2018年2月13日 · 年 2018

索引への追加 2026年3月11日

出典を開く

タグ

  • 脳卒中
  • 救急
  • 規制
  • コンピュータビジョン

教育と市場把握のための条目。医療助言でも推奨でもありません。

関連シナリオ

この領域のすべて

トリアージと救急

例示

A suggested emergency acuity for the triage nurse

This is an illustrative composite, not a trial report. As the triage nurse types the chief complaint and first vitals, a model suggests an acuity level. The nurse accepts or overrides it, and the accepted level is the one that enters the queue. The scenario is about keeping a human on the decision when under-triage would delay care. No accuracy percentage is claimed, because this entry is not a study.

EHR triage form · Local acuity model

病院 · 2026事例を読む

画像と放射線

規制

Autonomous diabetic retinopathy screening in primary care

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

ニュース · 2018事例を読む

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論文

AI-supported reading in the MASAI mammography trial

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.

Transpara 1.7.0 · ScreenPoint Medical

論文 · 2023事例を読む
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