FDA Radiology AI Devices

CINA-ASPECTS is a computer-aided diagnosis software designed to assist clinicians in evaluating brain tissue abnormalities using CT scans. It automatically analyzes regions of the brain affected by ischemic stroke, computes a standardized ASPECT score, and provides visual and quantitative data to support timely and accurate diagnosis of early acute stroke injury.

Rapid ASPECTS (v3) is a software tool designed to assist clinicians in evaluating brain CT images for early ischemic stroke. It automatically analyzes certain brain regions to generate an ASPECT Score, which helps characterize ischemic damage. This tool supports radiologists by providing standardized, AI-derived scores and annotated images, facilitating accurate and consistent stroke assessment to inform treatment decisions.

Brainomix 360 e-ASPECTS is an AI-powered software that analyzes non-contrast CT brain scans to assist clinicians in detecting and characterizing ischemic brain tissue injuries, particularly in cases of acute stroke caused by MCA or ICA occlusions. It automatically provides an ASPECTS score, highlights affected brain regions, and visualizes voxel contributions to the score, helping clinicians make timely and more accurate assessments to guide stroke treatment.

Optellum Virtual Nodule Clinic is an AI-powered software that helps medical professionals track, assess, and characterize pulmonary nodules detected incidentally in CT scans. It provides a malignancy likelihood score using a convolutional neural network to support clinical decision making, improving diagnostic accuracy and patient management workflows for lung nodules.

Rapid ASPECTS is an AI-powered software that helps doctors analyze CT brain scans to detect and score early signs of ischemic stroke by automatically segmenting brain regions and calculating an ASPECTS score. This aids clinicians in timely and accurate diagnosis, improving stroke assessment especially when expert radiologists are not immediately available.