Source record
Parallel notification of a suspected large-vessel occlusion
Ce texte est en anglais tant qu une traduction n est pas publiée.
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 févr. 2018 · Année 2018
- Evidence label
- Réglementaire
- Source type
- Actualité
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.
Fiche pour l éducation et la veille. Pas un avis médical ni un soutien.