FDA Radiology AI Devices

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.

The Avenda Health AI Prostate Cancer Planning Software is an AI-driven tool that assists physicians by segmenting prostate MR images, evaluating and quantifying lesions, and planning diagnostic or interventional procedures such as biopsies or tissue ablation. It provides a cancer probability map and confidence scores to help clinicians accurately characterize prostate cancer lesions, improving workflow efficiency and decision making in prostate cancer care.

Koios DS is a web-based AI software that helps trained physicians analyze ultrasound images of breast lesions and thyroid nodules suspicious for cancer. It automatically selects regions of interest, classifies lesions using standardized lexicons like BI-RADS and TI-RADS, provides cancer risk assessments, and generates structured reports to aid in clinical decision-making, improving diagnostic accuracy and reducing variability.

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.

EchoGo Pro is an AI-powered software tool designed to assist physicians in diagnosing coronary artery disease by analyzing stress echocardiography ultrasound images. It processes images acquired during stress echo exams, automatically segments the left ventricle, and uses machine learning to provide a categorical assessment of the likelihood of significant CAD, helping clinicians make more accurate and consistent diagnoses.

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.

Koios DS for Breast is a machine learning-based software that assists physicians in analyzing ultrasound images of breast lesions. It helps classify breast lesions into BI-RADS categories to support diagnostic accuracy, improve consistency between readers, and provide useful visual confidence indicators. The software processes selected regions of interest on ultrasound images and provides diagnostic support to clinicians.

QuantX is a software tool that helps radiologists analyze breast MRI images by automatically segmenting lesions and calculating a score based on lesion characteristics. It compares lesions in a patient's MRI to a database of known cases to help in diagnosing breast abnormalities, potentially improving diagnostic accuracy and consistency. It supports viewing multimodal images and generates structured reports to assist clinical decision-making.