FDA Radiology AI Devices

BriefCase by Aidoc Medical, Ltd. is an AI-powered radiological software that helps radiologists quickly identify head CTA images with suspected Large Vessel Occlusion. It provides notifications and compressed preview images in parallel to standard image interpretation to speed triage and prioritization, enhancing clinical workflow without replacing full diagnostic review.

syngo.CT CaScoring is a post-processing software that assists physicians in evaluating and documenting calcified coronary artery lesions using CT scans. It calculates detailed calcium scores for the coronary arteries and generates reports to aid in cardiac risk assessment, helping clinicians detect and quantify coronary artery disease.

Deep Learning Image Reconstruction software by GE Healthcare is an AI-powered CT image reconstruction tool that uses a deep neural network to produce high-quality CT images for head, whole body, cardiac, and vascular scans. It improves image noise, contrast detectability, and spatial resolution, helping clinicians obtain clearer images from CT scans for accurate diagnosis and patient care.

Cleerly Labs is a web-based software application that helps trained medical professionals view and analyze cardiac CT images, specifically from Coronary Computed Tomography Angiography (CCTA). It assists in identifying and measuring coronary artery plaques and stenosis to help evaluate coronary artery disease or suspected CAD, providing detailed visualizations and measurements to support clinical decision-making.

AI-Rad Companion (Cardiovascular) is an AI-powered software that analyzes previously acquired CT chest images to segment the heart and aorta, quantify coronary calcium, and measure aortic diameters. It assists clinicians by providing quantitative and qualitative cardiovascular assessments to support diagnosis and evaluation in emergency, specialty, and general practice care.

HeartFlow FFRct Analysis is a software tool that uses AI to analyze previously acquired coronary CT images (CT DICOM data). It creates a 3D computer model of the coronary arteries and simulates blood flow and pressure to help clinicians evaluate coronary artery disease. This aids in diagnosis and treatment planning by providing functional insights beyond traditional imaging.

AI-Rad Companion (Pulmonary) is advanced software designed to analyze CT images of the lungs. It helps clinicians by segmenting lung regions, measuring lung volumes, identifying areas with abnormal tissue density, and detecting lung lesions including solid pulmonary nodules. This enables efficient and precise assessment of lung disease from existing CT scans, supporting better diagnosis and treatment decisions in emergency and specialty care.

The iNtuition-Structural Heart Module by TeraRecon is a software tool designed to help cardiologists and radiologists visualize and measure structures of the heart and vessels. It supports image analysis, quantification of calcium, and provides detailed 2D/3D/4D visualizations to plan and evaluate cardiovascular interventions and surgeries, aiding clinicians in improved patient care.

DeepCT is an AI software tool that analyzes non-contrast CT brain images in acute settings to detect signs of intracranial hemorrhage. It sends notifications to specialists to prioritize and review cases quickly, improving workflow and potentially speeding patient care. It supports, but does not replace, radiologists' diagnostic process.

The Aquilion Precision (TSX-304A/1 and /2) V8.8 with AiCE is an advanced CT scanner that captures high-resolution 3D images of the whole body. It uses an AI-based algorithm called AiCE (Advanced intelligent Clear-IQ Engine) to reduce image noise and enhance image quality, which helps clinicians detect details more clearly. This makes diagnoses more accurate and can potentially reduce patient radiation exposure.