BriefCase-Triage
Aidoc Medical, Ltd.BriefCase-Triage by Aidoc Medical, Ltd. is an AI-powered software designed to assist radiologists by analyzing CT chest and abdomen scans and flagging cases with suspected aortic dissection. It helps medical specialists prioritize urgent cases by sending notifications and preview images, improving workflow efficiency without altering the original medical images or replacing diagnostic interpretation.
Intended Use
BriefCase-Triage is a radiological computer aided triage and notification software indicated for use in the analysis of CT chest, abdomen, or chest/abdomen exams with contrast (CTA and CT with contrast) in adults or transitional adolescents aged 18 and older. It assists hospital networks and appropriately trained medical specialists in workflow triage by flagging and communicating suspected positive findings of Aortic Dissection pathology.
Technology
The software is a radiological computer-assisted triage and notification tool based on a deep learning AI algorithm running on a linux-based cloud server. It processes filtered DICOM images chronologically to detect suspected cases, then sends low-quality grayscale preview images and notifications to a desktop application for user review. It functions in parallel to standard of care workflows without altering original images.
Performance
A retrospective, blinded, multicenter clinical study on 509 CT chest/abdomen exams with contrast showed the software achieved 92.7% sensitivity and 92.8% specificity in detecting Aortic Dissection, exceeding the 80% performance goal. Time-to-notification was significantly faster (10.7 vs 38.0 seconds) compared to the predicate device, demonstrating improved workflow efficiency while maintaining diagnostic accuracy.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
5/6/2025
24 days - 2
FDA Approval
5/30/2025
Other devices from Aidoc Medical, Ltd.
- BriefCase-Triage2025 • 510K
- BriefCase-Triage2024 • 510K
- BriefCase-Quantification2024 • 510K
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