Source record
Parallel notification of a suspected large-vessel occlusion
El texto se muestra en inglés hasta que exista una traducción.
The source is the U.S. FDA announcement of 13 February 2018 permitting marketing of Viz.ai ContaCT as clinical decision support that notifies providers of a potential stroke. FDA described a retrospective review of 300 CT angiograms against neuro-radiologists, plus real-world evidence aimed at earlier specialist notification. This entry does not restate a sensitivity. The labeled limit is notification, not a stand-alone diagnosis or a treatment decision.
- Source date
- 13 feb 2018 · Año 2018
- Evidence label
- Regulatorio
- Source type
- Noticia
Citation
U.S. FDA announcement, 13 February 2018
U.S. Food and Drug Administration. FDA permits marketing of clinical decision support software for alerting providers to a potential stroke. Press announcement, 13 February 2018. https://www.fda.gov/news-events/press-announcements/fda-permits-marketing-clinical-decision-support-software-alerting-providers-potential-stroke
Key public facts
- FDA permitted marketing of Viz.ai ContaCT on 13 February 2018 as notification software.
- The software analyzes brain CT angiography and can alert a specialist to a suspected large-vessel occlusion in parallel with the usual read.
- FDA described a retrospective set of 300 CT angiograms reviewed against neuro-radiologists, and real-world evidence aimed at earlier notification.
- This index does not restate a sensitivity figure from that review.
- The specialist still reviews full images. The product is not a diagnosis and not a treatment decision.
Ficha para educación y lectura de mercado. No es consejo médico ni un aval.