FDA Radiology AI Devices

CINA-VCF is an AI-powered software device designed to analyze chest and abdominal CT scans in patients aged 50 and above to identify suspected vertebral compression fractures. It operates alongside standard imaging workflows to prioritize and notify clinicians of potentially positive cases, helping improve triage speed and efficiency without altering original images or serving as a diagnostic tool itself.

The Rapid Aneurysm Triage and Notification device by iSchemaView Inc. is an AI-powered software designed to analyze CT angiography images of the head to detect suspected saccular aneurysms. It helps hospital networks and radiologists by prioritizing cases with potential aneurysms for faster review, improving workflow in routine patient care. The software provides notifications and compressed preview images for informational use, supporting radiologists in triage but not intended for diagnosis.

Viz AAA is an AI-powered software device designed to analyze CT angiogram images of the abdomen to detect suspected abdominal aortic aneurysms. It helps specialists prioritize patient studies by flagging those with potential aneurysms, improving workflow efficiency in clinical settings. The software provides non-diagnostic preview images and emphasizes that diagnostic decisions remain with treating specialists.

BriefCase is an AI-powered software by Aidoc Medical that automatically analyzes chest CT scans to identify cases with three or more acute rib fractures. It sends notifications with preview images to help radiologists prioritize these critical cases for faster review, enhancing clinical workflow and patient care without altering original images or providing primary diagnoses.

BriefCase by Aidoc Medical, Ltd. is an AI-powered software that assists radiologists by automatically analyzing chest and abdominal CT scans to detect and flag suspected vertebral compression fractures. It helps prioritize medical images for review, enabling faster triage without altering original images or workflows, thus improving the efficiency of radiological diagnosis and patient care.

Viz ANEURYSM is an AI-powered software that analyzes CT angiogram images of the head to detect suspected aneurysms of at least 4mm. It helps radiologists prioritize patient studies by flagging and highlighting cases with suspected aneurysms in a standalone application. This assists in faster triage and review, improving workflow efficiency while ensuring diagnostic decisions remain with the radiologist.

BriefCase for RibFx is an AI-powered software that assists medical specialists by analyzing chest CT scans to identify and flag cases with three or more acute rib fractures. It provides notifications and low-quality preview images on a desktop application, helping radiologists prioritize and review urgent cases sooner, thereby improving workflow efficiency and patient care.

The uAI EasyTriage-Rib is a software tool that uses artificial intelligence to analyze CT chest images and help radiologists prioritize trauma cases with suspected multiple acute rib fractures. It assists in workflow triage by flagging cases with suspected findings, allowing faster and more efficient patient management without altering the original medical images or making diagnoses itself.

HealthVCF is a software solution that uses artificial intelligence to analyze chest and abdominal CT scans to detect suspected vertebral compression fractures. It helps clinicians prioritize these cases for review within bone health programs by flagging them in a dedicated workstation application without interfering with the standard radiology workflow. The product aims to improve the speed of identifying at-risk patients but does not provide a diagnosis itself.