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RADIFY® Triage is a radiological computer-assisted triage and notification software that analyzes adult chest X-ray images for the presence of pre-specified suspected critical findings (pleural effusion and/or pneumothorax). RADIFY® Triage uses an artificial intelligence algorithm to analyze images for features suggestive of critical findings and provides case-level output available in the PACS for worklist prioritization or triage. As a passive notification for prioritization-only software tool within the standard of care workflow, RADIFY® Triage does not send a proactive alert directly to the appropriately trained medical specialists. The product is not intended to direct attention to specific portions of an image. Its results are not intended to be used on a stand-alone basis for clinical decision-making. The device does not remove the cases from the queue and does not flag the condition as being absent.

RADIFY® Triage is a radiological computer-assisted prioritization software that utilizes Albased image analysis algorithms to identify pre-specified critical findings (pleural effusion and/or pneumothorax) on frontal (AP and PA) views chest X-ray images and flag the images in the PACS to enable worklist prioritization by the appropriately trained medical specialists who are qualified to interpret chest radiographs. The software does not alter the order or remove cases from the reading queue. The algorithm was trained on datasets from US and non-USA sources. This training dataset consisted of 93.7% of the data from South Africa, and 6.3% of the data from the USA. The input for RADIFY® Triage is a frontal chest x-ray (AP and PA view) in digital imaging and communications in medicine (DICOM) format. Chest X-rays are sent to RADIFY® Triage via PACS (Picture Archiving and Communication System (PACS) and processed by the device for analysis. Following receipt of chest x-rays, the software device automatically analyses each image to detect features suggestive of pneumothorax and/or pleural effusion. Chest x-rays without the suspicious findings are placed in the worklist for routine review, which is the standard of care. RADIFY® Triage does not provide any proactive alerts and is not intended to direct attention to specific portions of the image. The results are not intended to be used on a standalone basis for clinical decision-making nor is it intended to rule out the target conditions or otherwise preclude clinical assessment of x-ray cases.