FDA Radiology AI Devices

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.

Venue Fit is a compact, portable diagnostic ultrasound system designed for use by trained healthcare professionals. It provides high-quality ultrasound imaging and fluid flow analysis across multiple clinical applications. The system supports standard ultrasound modes and includes AI-assisted features such as nerve tracking to help clinicians during procedures. Venue Fit enhances imaging capabilities and workflow efficiency in hospital and clinical settings.

Venue by GE Medical Systems is a general-purpose diagnostic ultrasound system designed for use by trained healthcare professionals. It offers ultrasound imaging, measurement, and analysis of the human body and fluids in a variety of clinical settings including hospitals and clinics. The device supports multiple clinical applications across different body regions and features automated tools to improve clinical workflow. Venue also includes AI-powered tools such as cNerve which assists in nerve detection and tracking during nerve block procedures, enhancing precision and patient safety.

Critical Care Suite with Endotracheal Tube Positioning AI Algorithm is a software tool that uses AI to automatically analyze frontal chest X-rays. It detects and localizes the position of an endotracheal tube and calculates the distance between the tube tip and the carina, providing clinicians with important information on tube placement to improve patient care.