FDA Radiology AI Devices

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.

Critical Care Suite with Pneumothorax Detection AI Algorithm by GE Medical Systems is an AI-based software tool that analyzes frontal chest X-rays to detect pneumothorax. It highlights areas of concern and provides a confidence score, helping radiologists and licensed healthcare professionals prioritize cases and accurately diagnose pneumothoraces more efficiently. The software can be integrated with existing PACS and X-ray imaging systems to streamline workflow.

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.

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.

FractureDetect (FX) is an AI-powered software that analyzes X-ray images of bones to help doctors detect fractures. It highlights areas on radiographs where fractures are detected, improving accuracy and efficiency in diagnosis for various bone regions in adults.

OsteoDetect is an AI-driven software that helps clinicians detect distal radius fractures on adult wrist X-rays. It analyzes both posterior-anterior and lateral radiographs, highlighting potential fractures with bounding boxes to assist healthcare providers in diagnosing wrist injuries more accurately and quickly. The software serves as an adjunct, supporting clinical decision-making but not replacing the clinician's judgment.