FDA Radiology AI Devices

VEA Align; spineEOS by EOS imaging is an AI-based software designed to automatically process radiological images of the spine. It helps clinicians by aligning and analyzing spinal images, improving accuracy and efficiency in diagnosing and treatment planning for spinal conditions.

Brainlab Elements (7.0) is a suite of medical imaging software applications that aid clinicians in planning cranial and extracranial surgical and radiotherapy treatments. It provides tools for image fusion (aligning different imaging datasets), angiographic image registration, contouring (outlining anatomical structures), fibertracking (visualizing brain white matter tracts from diffusion imaging), and functional MRI mapping. The device supports precise treatment planning by combining and analyzing various imaging data, helping clinicians visualize critical anatomical and functional areas without being used for diagnostic purposes.

LungVision is an AI-powered software system that helps clinicians navigate tools within the lungs during procedures. It combines previously acquired 3D CT images with real-time fluoroscopic X-ray images to provide detailed guidance for targeting lung lesions, thus enhancing the precision of pulmonary interventions.

Preview Shoulder is a software tool designed to help orthopedic surgeons plan shoulder surgery using 3D models created from CT scans. It allows surgeons to place digital implants within the shoulder anatomy and generate detailed surgical plans to improve surgical outcomes. This software is used as a pre-operative planning aid and is intended for adult patients only, not for diagnostic purposes.

Brainlab Elements is a suite of software applications that process and analyze medical image data from various modalities to assist clinicians in planning surgeries and radiation treatments. It offers tools for image registration (fusion), segmentation (contouring), diffusion tensor imaging (fibertracking), blood oxygen level dependent MRI analysis (BOLD MRI mapping), and cerebrovascular image fusion (Image Fusion Angio). These capabilities help improve precision and understanding of patient anatomy and function during clinical procedures.

ViewFinder Software Version 1.1 by Elaitra Ltd is a specialized software tool designed for clinicians to review digital breast tomosynthesis images. It dynamically matches tissue across different breast views using AI to reduce cognitive load, helping radiologists to compare images more efficiently and accurately during breast cancer screening and diagnosis.