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규제뉴스

Parallel notification of a suspected large-vessel occlusion

이 언어의 본문은 아직 없어 영어로 보여 줍니다.

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.

임상 현장

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.

도구와 공급사

  • Viz.ai ContaCT

출처가 보고한 내용

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.

출처

U.S. FDA announcement, 13 February 2018 · 2018년 2월 13일 · 연도 2018

색인 추가일 2026년 3월 11일

출처 열기

태그

  • 뇌졸중
  • 응급
  • 규제
  • 컴퓨터 비전

교육과 시장 탐색용 항목. 의학 조언도 추천도 아닙니다.

분류와 응급

예시

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

병원 · 2026사례 읽기

영상과 영상의학

규제

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

뉴스 · 2018사례 읽기

영상과 영상의학

논문

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

논문 · 2023사례 읽기
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