FDA Radiology AI Devices

Rayvolve LN is an AI-powered software that helps radiologists detect and highlight suspected pulmonary nodules on frontal chest X-rays. By serving as a second reader, it aids in reviewing digital radiographs for patients 18 years or older, enhancing diagnostic accuracy without replacing the original chest images.

SnapshotGLO is a handheld, point-of-care imaging device that helps clinicians visualize and document skin wounds using autofluorescence technology. It captures images of wounds under excitation light to highlight areas with bacterial presence, enhancing wound assessment alongside clinical signs and symptoms. It is intended as an adjunct tool to aid in wound diagnosis and monitoring but does not itself diagnose or treat wounds.

The VERAFEYE System by Luma Vision Limited is an advanced ultrasound imaging tool designed for real-time visualization inside the heart and great vessels during cardiac procedures. It includes a sterile catheter and an imaging console that creates 2D and 3D ultrasound images to help clinicians see cardiac anatomy and physiology, guiding interventions safely and accurately.

The ARVIS Surgical Navigation System assists surgeons during orthopedic surgeries by providing real-time, augmented reality-based visualization and precise intraoperative measurements to aid in positioning and aligning implants. It enhances surgical accuracy in procedures such as knee and hip arthroplasties, improving outcomes and helping surgeons make informed decisions during operations.

The Philips Holter Analysis System is a standalone software designed to analyze ambulatory ECG recordings collected over extended periods (typically 24 hours to 7 days). It automatically processes ECG data to detect heart rhythm disturbances, arrhythmias, pacemaker function, and myocardial ischemia-related symptoms, providing reports to assist clinicians in evaluating cardiac health. The system enhances arrhythmia detection algorithms and heart rate variability analysis and integrates with clinical information systems for streamlined ECG data management.

Rayvolve PTX-PE is an AI-based software tool designed to automatically analyze chest X-ray images for critical findings like pleural effusion and pneumothorax. It helps healthcare professionals prioritize cases by providing study-level notifications for worklist management, thereby improving the efficiency of radiological workflows without replacing clinical decision-making.

brAIn™ Shoulder Positioning is a cloud-based software tool that assists shoulder surgeons in planning total shoulder replacement surgeries. It automatically segments CT images of the shoulder using machine learning, allowing clinicians to visualize shoulder anatomy, position implants interactively in 3D, and receive detailed pre- and post-operative measurements and reports, facilitating more accurate and efficient surgical planning.

The EXPD 114 series are digital flat panel X-ray detectors designed to capture radiographic images electronically instead of traditional film. These devices convert incoming X-rays into visible light and then into digital signals for immediate viewing, storage, and analysis. The detectors are intended for general radiographic diagnosis and can replace traditional film or screen-based systems, assisting clinicians with quick and efficient patient imaging for a wide range of examinations in both adult and pediatric populations.

The Starlight Imaging Catheter is a sterile, single-use catheter designed for imaging coronary arteries in patients undergoing transluminal interventional procedures. It uses near-infrared light and an internal rotating fiber optic core to capture detailed cross-sectional images inside vessels, helping clinicians assess vessel condition and guide interventions safely and effectively.

Vent Creativity Knee v1.0 (Hermes) is a software tool that processes CT scan images of the knee to segment bones and generate surgical planning data. It uses AI models to accurately identify bone structures and landmarks, aiding clinicians in diagnosis and preoperative planning. The software also supports the creation of physical replicas based on imaging data, facilitating orthopedic applications.