FDA Radiology AI Devices

SwiftMR is a software tool that automatically enhances MRI images by reducing noise and increasing sharpness using deep learning techniques. It integrates with medical imaging systems (PACS or MRI machines) to improve image quality, aiding radiologists and clinicians in better interpreting MRI scans.

Veuron-Brain-pAb3 is advanced software that processes PET and MRI brain images to help clinicians detect and quantify amyloid protein concentration as an aid in diagnosing dementia. It automates image registration, fusion, and calculates standard uptake value ratios (SUVR) to visualize and analyze brain pathologies, improving diagnostic accuracy and workflow efficiency.

The OFIX MIS App is a mobile software application designed to help healthcare professionals view, store, and measure images to plan orthopedic surgeries, specifically for spinal implant procedures. It uses images captured via a mobile phone camera to assist in selecting the correct rod length for pedicle screw spinal systems, aiding surgeons in making precise implant placement decisions.

Jazz is a semi-automatic medical image processing software designed to assist physicians in labeling, visualizing, and measuring volumes of brain structures from MRI scans. It is intended for use with patients diagnosed with multiple sclerosis or brain metastases, enabling physicians to review, correct, and confirm segmentations before generating radiological reports, thereby supporting clinical workflows for brain imaging analysis.

NEUROShield is a software tool that automatically labels, visualizes, and measures the volume of the hippocampus brain structure using 3D MRI images. It uses AI deep learning models to assist neurologists and neuroradiologists by providing fast, accurate volumetric analysis, helping in clinical decision-making and research.

AIRAscore is an AI-powered software that automates the identification, labeling, and volumetric measurement of brain structures from MRI scans. It helps clinicians quickly obtain detailed brain volume information, which can aid in diagnosis and monitoring of neurological conditions by providing consistent and accurate brain segmentation results.

Autoplaque 3.0 is a post-processing software designed for use with coronary CT angiography images. It helps cardiologists and radiologists analyze coronary arteries to detect and measure plaques and stenosis. The AI-driven software automates vessel, plaque, and lumen segmentation with an option for clinician review, enabling faster and more standardized cardiac image analysis.

SubtleMR (2.3.x) is an AI-powered software that improves MRI images by reducing noise or enhancing sharpness. It supports MRI scans of various body regions such as head, spine, abdomen, and more. This helps clinicians obtain clearer images, potentially improving diagnostic accuracy without additional scans or equipment.

Neurophet AQUA is a software tool that helps clinicians and researchers analyze brain MRI scans by automatically identifying and measuring brain structures. It generates detailed reports comparing patient brain volumes to reference data, aiding in the assessment of neurological conditions and monitoring structural brain changes.

MR DWI/FLAIR Measurement V1.0 is a medical image processing software developed by Olea Medical that analyzes MRI brain images from diffusion-weighted imaging (DWI) and fluid-attenuated inversion recovery (FLAIR) sequences. It automatically computes diffusion maps and extracts relevant metrics to assist medical professionals in evaluating brain conditions. The software integrates with existing medical imaging platforms and helps clinicians by providing quantitative analysis to complement their diagnosis and treatment planning.