BriefCase

BriefCase is a radiological software tool that employs an artificial intelligence algorithm to analyze non-enhanced head CT and CTPA images for suspected Intracranial Hemorrhage and Pulmonary Embolism, aiming to expedite radiologist review of critical cases. By providing automated notifications and non-diagnostic preview images in parallel to standard care, the system facilitates workflow triage and prioritization without altering original medical data or replacing definitive diagnostic interpretation.

BriefCase is a radiological computer-aided triage and notification software developed by Aidoc Medical, Ltd., designed to assist hospital networks and trained radiologists in managing their workflow for urgent cases. Its core function is to analyze non-enhanced head CT images for suspected Intracranial Hemorrhage (ICH) and single-energy CT Pulmonary Angiography (CTPA) images for suspected Pulmonary Embolism (PE). The system utilizes an artificial intelligence algorithm to automatically detect these critical findings, subsequently flagging relevant studies to facilitate earlier review and prioritization by medical professionals. The BriefCase system operates by processing DICOM images chronologically through its AI algorithm. Upon detection of suspected ICH or PE, it sends notifications to a dedicated Worklist Application on the radiologist's desktop, functioning in parallel with, and without altering, the standard image interpretation workflow or the original medical images. These notifications include patient identifiers, the suspected pathology, and a compressed, non-diagnostic preview image intended solely for informational triage purposes. Performance data from studies indicated high sensitivity (e.g., 90.6% for PE in a pivotal study) and specificity (e.g., 89.9% for PE), and demonstrated a significant reduction in the time-to-notification for true positive PE cases (mean 3.9 minutes with BriefCase versus 64.1 minutes standard care time-to-exam-open). The software is not a diagnostic tool; radiologists must use the original images in PACS for diagnosis, with BriefCase serving to highlight potentially critical studies for faster attention.

AI Regulatory Concerns

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Jev reads the full FDA letter and returns calibrated concern probabilities per regulatory category. These are AI estimates, not regulatory advice.

• Q1. How does the BriefCase AI algorithm's performance (sensitivity and specificity) for PE and ICH detection vary across different CT scanner manufacturers, models, and imaging protocols encountered in real-world clinical settings?; What is the observed false positive notification rate for PE and ICH in diverse clinical environments, and what is its quantifiable impact on radiologist workflow, including potential alert fatigue?; Are there specific subtypes or severities of Intracranial Hemorrhage or Pulmonary Embolism where the BriefCase software demonstrates notably higher or lower detection accuracy?; Beyond time-to-notification, what is the measurable impact of BriefCase implementation on downstream clinical metrics, such as time-to-treatment initiation or patient outcomes for acute PE and ICH cases?; What are the technical integration requirements and challenges for deploying BriefCase within existing hospital IT infrastructures, particularly concerning DICOM routing, server load, and cybersecurity for the cloud component?