BriefCase
Aidoc Medical, Ltd.BriefCase by Aidoc Medical, Ltd. is an AI-based radiology triage and notification software designed to assist radiologists by automatically analyzing head CT and chest CT pulmonary angiogram (CTPA) images. It detects suspected cases of Intracranial Hemorrhage and Pulmonary Embolism, providing timely notifications and compressed preview images to prioritize urgent cases. This facilitates faster review and potentially improves patient outcomes by allowing earlier intervention, while not replacing standard diagnostic processes.
Intended Use
BriefCase is a radiological computer aided triage and notification software indicated for use in analysis of non-enhanced head CT and CTPA images to assist hospital networks and radiologists in workflow triage by flagging suspected positive findings of Intracranial Hemorrhage (ICH) and Pulmonary Embolism (PE).
Technology
The system includes AI algorithms for image analysis running on Windows servers supported by components such as PostgreSQL and DICOM modules. It processes DICOM images, de-identifies data, analyzes each series chronologically, and sends notifications with compressed previews to radiologists' desktop applications. The device does not alter original images and does not remove cases from the standard workflow queue.
Performance
Performance studies include a retrospective single-center pilot with 2,803 CTPA exams showing 93.0% sensitivity and 93.7% specificity, and a multicenter study with 184 cases showing 90.6% sensitivity and 89.9% specificity. Additionally, time-to-notification was significantly faster (3.9 minutes) than standard radiologist review (64.1 minutes), potentially allowing earlier clinical intervention.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
1/15/2019
3 months - 2
FDA Approval
4/15/2019
Other devices from Aidoc Medical, Ltd.
- BriefCase-Quantification2024 • 510K
- BriefCase-Triage2024 • 510K
- BriefCase-Triage2024 • 510K
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