FDA Radiology AI Devices

BriefCase-Triage is an AI-powered software designed to analyze CT scans of the cervical spine in adults, helping hospital networks and medical specialists by flagging potential fractures. It provides notifications and preview images of suspected cases, enabling faster prioritization of urgent findings to improve clinical workflow and patient care, while not altering original diagnostic images.

CINA-CSpine by Avicenna.AI is a radiological computer-assisted triage and notification software that uses AI algorithms to analyze cervical spine CT scans for suspected acute fractures. It helps hospital networks and trained physicians by flagging potential fracture cases and prioritizing image review, enabling faster and more efficient diagnosis and patient care. It operates alongside the standard care workflow without altering original images, providing notifications with preview images for informational purposes.

Rayvolve by AZmed SAS is an AI-powered software designed to assist radiologists and emergency physicians in detecting fractures from X-ray images of various musculoskeletal regions in adults and children aged 2 years and older. It enhances fracture diagnosis by automatically highlighting potential fractures on standard radiographic views, improving diagnostic accuracy and workflow efficiency.

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.

Annalise Enterprise CXR Triage Trauma is an AI-based software tool designed to assist clinicians by analyzing adult chest X-ray images to detect features suggestive of vertebral compression fractures. It integrates with hospital image and order management systems to prioritize cases with potential fractures, facilitating timely review in clinical workflows such as Bone Health and Fracture Liaison Service programs. The device supports clinicians in identifying urgent cases but does not replace clinical decision-making.

BoneView 1.1-US is an AI-powered software designed to assist clinicians by analyzing X-ray radiographs to identify and highlight fractures. It works as a concurrent reading aid, helping improve the accuracy and speed of fracture diagnosis across multiple anatomical regions including limbs, pelvis, ribs, and spine for both adults and pediatric patients. The software integrates seamlessly with imaging systems like PACS and can be deployed on-premise or in the cloud, enhancing radiologists' ability to detect subtle and definite fractures.

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.

Rayvolve is an AI-powered software tool that helps radiologists and emergency physicians detect fractures on X-rays of the musculoskeletal system. It analyzes various standard radiographic views of bones like ankle, clavicle, elbow, hip, knee, and more, providing accurate fracture detection to support clinical decision-making.

BoneView by Gleamer is an AI-powered software that analyzes X-ray images of bones to detect and highlight fractures. It acts as a concurrent reading aid for clinicians, improving the accuracy and confidence of fracture diagnosis from radiographs across a wide range of anatomical areas. By providing clear visual annotations, it helps reduce missed fractures and supports better patient care.