BriefCase
Aidoc Medical, Ltd.BriefCase by Aidoc Medical is an AI-powered software that analyzes CTPA images to detect suspected Pulmonary Embolism cases and notifies clinicians via a desktop application to prioritize these potentially critical cases. It works alongside the standard image interpretation process, helping healthcare professionals triage faster and improve patient care without altering original medical images.
Intended Use
Radiological computer aided triage and notification software for analysis of CTPA images in adults or transitional adolescents aged 18 and older, intended to assist hospital networks and trained medical specialists in workflow triage by flagging suspected positive Pulmonary Embolism findings.
Technology
An AI deep learning algorithm running on a software system with modules including an image acquisition server, a cloud processing server, and a desktop application interface. It processes DICOM CT images by filtering, de-identifying, and analyzing series chronologically to detect suspected PE cases and sends notifications with compressed preview images to clinicians without modifying the original images.
Performance
A multicenter retrospective blinded study on 499 CTPA cases showed sensitivity of 94.86% and specificity of 94.04% exceeding the 80% performance goal. Time-to-notification averaged 78 seconds, significantly faster than the predicate device's 234 seconds, supporting faster triage. Additional operating points optimized sensitivity or specificity also met performance goals.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
7/29/2022
28 days - 2
FDA Approval
8/26/2022
Other devices from Aidoc Medical, Ltd.
- BriefCase-Quantification2024 • 510K
- BriefCase-Triage2024 • 510K
- BriefCase-Triage2024 • 510K
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