FDA Radiology AI Devices

VUNO Med-DeepBrain is an AI-powered medical software designed to automatically label, quantify, and visualize brain structures and lesions from MR images. It helps clinicians by automating manual brain segmentation processes, providing volumetric data along with visual color maps and reports, facilitating brain diagnosis and tracking over time in a clinical environment.

HipCheck is a software tool used during hip arthroscopy surgeries that helps surgeons measure the alpha angle related to femoroacetabular impingement (FAI). It processes X-ray images taken during surgery and overlays virtual measurement tools on these images to support clinical decision-making. It also includes a patient-specific report feature for preoperative planning using three-dimensional analyses and visualizations of the hip.

qXR-CTR is an AI-powered software that helps physicians automatically measure the cardiothoracic ratio—the size of the heart relative to the chest—using chest X-ray images. It analyzes images to provide quick, accurate measurements that support clinical decision-making, making the process more efficient for healthcare providers.

DeepXray is an AI-powered software that helps medical professionals analyze knee X-rays by automatically measuring joint space width and assessing signs of osteoarthritis such as sclerosis, joint space narrowing, and osteophytes. It supports clinicians by providing detailed grading based on established radiographic criteria and offers an interactive report for review and editing before finalizing.

ANDI is a software tool that processes diffusion-weighted MRI brain scans to create 3D maps of white matter tracts. It helps neurologists and radiologists by providing detailed visualization and measurements of brain white matter structures, serving as an adjunct tool for patient assessment without making diagnoses.

OptimMRI is a software tool that helps medical professionals analyze pre-operative brain MRI images by generating 3D annotated models. It supports neurosurgical planning by localizing key brain regions, helping doctors visualize and plan treatments more precisely.

uOmnispace is a medical image post-processing software solution that supports viewing, manipulation, annotation, and communication of various medical images from multiple modalities including CT, MRI, PET and DR. It includes AI-based segmentation tools like rib segmentation, and enables remote multi-user access and integration with medical imaging systems. It helps clinicians efficiently analyze and report on diagnostic images.

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.

Spine CAMP™ (1.1) is an automated software that analyzes X-ray images of the lumbar and cervical spine to generate measurements and visualizations of spinal alignment, stability, degeneration, and motion. It supports healthcare professionals in clinical decisions related to spinal health by producing detailed reports from radiographic data.

Axial3D Insight is a cloud-based service that processes medical imaging DICOM data to create detailed 3D digital files or physical 3D printed models. These models assist clinicians in treatment planning and diagnosis across orthopedic trauma, maxillofacial, and cardiovascular applications, improving surgical preparation and outcomes.