BriefCase is an AI-powered software that assists radiologists by analyzing non-enhanced head CT images to detect suspected intracranial hemorrhages. It provides timely notifications with preview images to prioritize cases for faster review, helping clinicians improve workflow efficiency and patient care without altering original images or making diagnoses.
BriefCase is a radiological computer aided triage and notification software indicated for use in the analysis of non-enhanced head CT images to assist hospital networks and radiologists by flagging and communicating suspected intracranial hemorrhage findings to support prioritization of image review.
BriefCase is a software system comprising three modules (Hospital Server, Cloud Server, Worklist Application) that receives DICOM images, processes them with a deep learning AI algorithm to detect suspected intracranial hemorrhage. It sends notifications and compressed preview images to radiologists' desktops for parallel workflow triage without altering original images or removing cases from reading queues.
A retrospective, blinded, multicenter study with 198 cases showed BriefCase sensitivity of 93.6% and specificity of 92.3% for detecting intracranial hemorrhage. Time-to-notification averaged 4.5 minutes compared to 72.6 minutes for standard care exam opening, potentially saving 68 minutes in triage prioritization for true positive cases.
No predicate devices specified
Submission
3/12/2018
FDA Approval
8/1/2018
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