FDA Radiology AI Devices

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.

MOZI TPS is a radiation therapy planning software that helps clinicians design and optimize treatment plans for patients with malignant or benign diseases. It uses medical images to assist in contouring anatomical structures automatically with deep learning, performs image registration, and calculates radiation dose distribution using Monte Carlo algorithms. This aids clinicians in accurately planning external beam irradiation with photon beams, improving treatment effectiveness and patient safety.

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.

Bladder AI is a software designed to assist healthcare providers in measuring bladder volume from ultrasound images using machine learning. It supports image-based assessment, landmark placement, and report generation for patients aged 2 years and older, improving workflow efficiency and accuracy in bladder volume quantification.

HepaFatSmart (V2.0.0) is an automated AI-assisted software that analyzes magnetic resonance imaging (MRI) datasets to measure liver fat quantitatively. It calculates volumetric liver fat fraction (VLFF), proton density fat fraction (PDFF), and steatosis grading without user input, supporting clinical diagnosis and management of fatty liver disease and screening of liver transplant donors. This software helps clinicians by providing consistent, reproducible liver fat measurements from MRI scans, aiding patient care in liver-related conditions.

DeepCatch is software that analyzes whole-body CT scans to automatically identify and measure various anatomical structures like skin, muscle, fat, internal organs, and the central nervous system. It produces 3D models and quantitative data to help doctors better understand the patient's body composition and anatomy, aiding clinical decisions by providing accurate volume and proportion measurements.

CAC Software by Imbio, Inc. is a machine learning-based post-processing tool that analyzes non-contrast CT images of the chest to assess calcified plaques in the coronary arteries. It quantifies the calcification burden by producing scores and metrics that help clinicians evaluate coronary artery disease risk. The software outputs annotated images and a detailed report, integrating into the standard DICOM workflow to assist physicians without making standalone diagnoses.

FEops HEARTguide™ ALPACA is an AI-enabled medical imaging software system that helps clinicians visualize and measure detailed heart and vessel structures from CT images. It aids in planning minimally invasive heart procedures by providing automated segmentation, 3D visualization, measuring tools, and reporting. This software supports better procedural decisions by combining anatomical insights with clinical evaluation.