FDA Radiology AI Devices

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.

HealthPPT is an AI-powered software tool that helps radiologists by automatically detecting signs of pneumoperitoneum in adult frontal chest X-rays. It prioritizes urgent cases by notifying the radiology workstation with a low-resolution preview image, enabling faster review of potentially critical findings. The device works alongside standard workflows without altering original images and does not itself diagnose the condition, but aids clinical assessment by highlighting suspicious cases for prompt review.

Lunit INSIGHT CXR Triage is an AI-based software tool designed to analyze adult chest X-ray images and identify potentially critical lung conditions such as pleural effusion and pneumothorax. It flags suspicious cases in the radiology workflow, enabling radiologists to prioritize urgent cases more efficiently without altering the standard reading queue. It operates as a supportive notification system and is not intended for standalone clinical decision making.

Saige-Q is a software tool that analyzes digital breast mammograms using artificial intelligence to identify exams that may contain suspicious findings suggestive of breast cancer. It helps radiologists prioritize these exams in their worklist, enabling faster review of potentially concerning cases. The tool provides passive notification codes but does not provide diagnostic decisions and supports both full-field digital mammography and digital breast tomosynthesis images.

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.

HealthMammo is an AI-enabled software tool designed to analyze 2D full-field digital mammograms to identify and flag suspicious findings. It assists radiologists by prioritizing mammogram cases in the PACS/worklist, helping clinicians review critical cases faster and improve workflow efficiency without replacing diagnostic evaluation.

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.

AIMI-Triage CXR PTX by RADLogics is an FDA-cleared AI software that helps hospital radiologists prioritize adult chest X-rays that might show moderate to large pneumothorax. It analyzes chest X-rays and flags urgent cases for quicker review, improving workflow and patient care by notifying radiologists of possible urgent findings without replacing full diagnosis.

The Behold.ai Red Dot device is an AI-powered software platform that assists radiologists by automatically analyzing adult chest X-ray images to identify suspected pneumothorax cases. It integrates into clinical workflows by notifying radiologists through PACS or workstation systems to prioritize these cases for faster review. It is intended to support, but not replace, clinical decision-making.