Radify Triage
Envisionit DeepAI LtdRadify Triage is an AI-powered software that analyzes adult chest X-ray images to detect critical findings like pleural effusion and pneumothorax. It provides a notification within the PACS system to help radiologists prioritize urgent cases, improving workflow efficiency and patient care. It acts as a triage tool to flag suspicious cases but does not replace clinical decision-making.
Intended Use
Radify Triage is a radiological computer-assisted triage and notification software that analyzes adult chest X-ray images for pre-specified suspected critical findings (pleural effusion and/or pneumothorax). Provides case-level output in the PACS for worklist prioritization or triage, as a passive notification for prioritization-only within a standard care workflow without sending proactive alerts.
Technology
Software uses AI algorithm (Deep Convolutional Neural Networks) to analyze frontal chest X-rays (AP and PA views) in DICOM format for pneumothorax and pleural effusion features. It integrates with PACS to flag images for prioritization without marking images or removing cases from the queue.
Performance
Clinical validation showed high accuracy in detecting pneumothorax and pleural effusion on chest X-rays with AUC > 0.95, sensitivity > 94%, and specificity > 96%. Testing used retrospective US datasets with independent ground truth from board-certified radiologists. Average notification time in PACS was 3 seconds.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
6/26/2023
6 months - 2
FDA Approval
1/17/2024
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