FDA Radiology AI Devices

The syngo.via MI Workflows, including Scenium and syngo MBF, is a multi-modality software platform developed to assist healthcare professionals in viewing, manipulating, quantifying, and analyzing medical images from various imaging modalities, including PET, SPECT, CT, and MR. It supports disease management in oncology, cardiology, neurology, and organ function, and aids physicians in radiotherapy treatment planning by harmonizing PET data and providing standardized analysis tools such as brain amyloid quantification.

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.

The EFAI Bonesuite XR Bone Age Pro Assessment System (BAP-XR-100) is software that uses deep learning to analyze left-hand X-ray images in pediatric patients aged 2 to 16 years. It estimates bone age to assist pediatric radiologists in clinical decision-making. The system integrates with existing PACS workflows, providing bone age assessments to support but not replace radiologist interpretation.

LVivo IQS is an AI-powered platform designed to analyze ultrasound images of the heart, specifically providing real-time quality scoring of right ventricle images from the 4-chamber apical view. This software helps clinicians by automatically detecting, measuring, and calculating important cardiac parameters and providing feedback on image quality, enhancing the reliability and interpretability of ultrasound examinations.

Rho is a machine learning software that analyzes standard frontal x-rays of various body parts in patients aged 50 and older to identify possible low bone mineral density. It helps radiologists by generating reports suggesting patients who may benefit from further clinical bone health assessment, thereby assisting in early detection and management of bone health issues.

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.

Fibresolve is a software device that analyzes lung CT images using deep learning to identify patterns suggestive of idiopathic pulmonary fibrosis. It provides a binary output to assist clinicians in diagnosing fibrotic lung disease, serving as an adjunct tool in the diagnostic workflow especially before invasive testing, helping to improve early detection and referral for appropriate clinical discussion.

Transpara Density 1.0.0 is an AI-powered software designed to assist healthcare professionals in assessing breast tissue composition from digital mammography and tomosynthesis images. It automatically calculates volumetric breast density, breast volume, and categorizes breast density according to ACR BI-RADS 5th Edition. This helps radiologists make informed decisions about breast cancer screening and diagnosis.

The Myocardial Strain Software Application by Circle Cardiovascular Imaging is a software tool that analyzes cardiac MRI images to provide detailed measurements of heart muscle deformation. It helps clinicians assess myocardial function by computing metrics like strain, displacement, velocity, and torsion, supporting diagnostic decisions in patients with suspected heart disease.