FDA Radiology AI Devices

StrokeSENS ASPECTS Software Application by Circle Cardiovascular Imaging Inc. is a computer-assisted diagnostic tool designed to assist clinicians in evaluating lesions suspicious for cancer, potentially improving diagnostic accuracy in radiology.

Fetal EchoScan (v1.1) is an AI-driven software device that assists physicians in interpreting second-trimester fetal heart ultrasound videos. It detects suspicious morphological features indicative of congenital heart defects, helping clinicians identify potential heart abnormalities in unborn babies during routine ultrasound exams. The software acts as a concurrent reading aid, providing annotative outputs to improve diagnostic accuracy and support clinical decision-making for fetal cardiac assessment.

Sonio Suspect is a cloud-based AI software designed to assist clinicians during or after fetal ultrasound examinations by automatically detecting and characterizing abnormal fetal findings. It helps healthcare professionals identify potential issues in fetal development, improving diagnostic accuracy and supporting better patient management decisions.

Brainomix 360 e-ASPECTS is an AI-based software that analyzes non-contrast CT brain scans to help clinicians assess ischemic brain tissue injury and calculate an ASPECTS score, which reflects the extent of stroke-related brain damage. It uses automated image processing and machine learning to highlight affected brain regions, providing decision support for stroke diagnosis and treatment.

Koios DS is an artificial intelligence software tool that helps trained physicians analyze ultrasound images of breast lesions and thyroid nodules. It processes user-selected regions within the images to provide AI-derived risk assessments for cancer, and generates descriptors following established medical lexicons to improve diagnostic accuracy and reduce variability among physicians. The software also functions as an image viewer and supports image annotation and reporting, helping clinicians make more informed decisions in managing patients with suspicious lesions.

Fetal EchoScan is an AI-powered software tool that assists physicians in analyzing fetal heart ultrasound videos during the second trimester. It helps identify suspicious anatomical findings that may indicate fetal congenital heart defects, enhancing diagnostic accuracy and aiding clinical decision-making without replacing standard care.

EchoSolv AS is a cloud-based AI and machine learning decision support software designed to help cardiologists assess severe aortic stenosis (AS) from transthoracic echocardiogram data and patient demographics. It provides a categorical probability of severe AS to assist in diagnosis alongside clinical guidelines, improving identification accuracy and supporting patient management decisions during echocardiogram interpretation.

AISAP Cardio V1.0 is an AI-powered software that analyzes cardiac point-of-care ultrasound images to detect and assess valvular pathologies like regurgitations and stenosis, and measures key cardiac functions such as ejection fraction and chamber sizes. It supports physicians by generating diagnostic reports that aid in interpreting ultrasound images, improving accuracy and efficiency in evaluating heart conditions in adult patients.

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.