BriefCase
Aidoc Medical, Ltd.BriefCase by Aidoc Medical, Ltd. is an AI-powered software that analyzes contrast-enhanced chest CT scans to detect incidental pulmonary embolism. The software notifies radiologists of suspected positive cases via a desktop application, helping prioritize urgent cases for faster review without replacing the standard diagnostic process. It supports workflow improvements by flagging cases early, potentially saving hours in time to examination.
Intended Use
BriefCase is a radiological computer aided triage and notification software indicated for use in the analysis of contrast-enhanced chest CT images (but not dedicated CTPA protocol). It assists hospital networks and trained radiologists by flagging and communicating suspected positive cases of incidental Pulmonary Embolism (iPE).
Technology
BriefCase is a software system that includes three modules: Aidoc Hospital Server for image acquisition, Aidoc Cloud Server for image processing, and Aidoc Worklist Application for workflow integration. It processes DICOM images from compatible CT scanners (GE and Siemens), runs AI algorithms to detect suspected incidental PE cases, and sends notifications with compressed, non-diagnostic preview images to radiologist workstations for triage support.
Performance
A retrospective, blinded multicenter study with 268 chest CT cases (74 positive for iPE, 194 negative) showed that BriefCase achieved a sensitivity of 90.5% and specificity of 88.7% for detecting incidental pulmonary embolism. Time-to-notification was approximately 4.7 minutes versus standard radiologist time-to-exam-open of 223.3 minutes, potentially saving over 3 hours in clinical workflow. The negative predictive value was 99.7%.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
4/17/2020
4 months - 2
FDA Approval
8/26/2020
Other devices from Aidoc Medical, Ltd.
- BriefCase-Quantification2024 • 510K
- BriefCase-Triage2024 • 510K
- BriefCase-Triage2024 • 510K
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