FDA Radiology AI Devices

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.

The Stethee Pro 1 is an electronic stethoscope designed for medical screening and diagnostic use. It detects and amplifies sounds from the heart, lungs, and other internal organs, and works with the Stethee Pro Software System to record, visualize, analyze, and share these sounds. This helps clinicians better assess patient heart and lung conditions through enhanced audio and data analysis tools.

Cleerly Labs v2.0 is a web-based software that assists trained medical professionals by analyzing coronary CT images to detect atherosclerosis and stenosis. It uses AI to segment and label coronary arteries, enhancing efficiency and accuracy in diagnosing coronary artery disease and supporting clinical decision making.

LVivo Seamless is an AI software application that automatically analyzes echocardiogram ultrasound images to assess cardiac function by calculating parameters like ejection fraction (EF). It helps clinicians by streamlining the evaluation process, sending analyzed results directly to PACS for review, enhancing diagnostic efficiency and accuracy for patients with suspected cardiac disease.

Caption Guidance is an AI-powered software accessory designed to assist medical professionals in acquiring high-quality cardiac ultrasound images. It provides real-time feedback and guidance to help users obtain standard echocardiographic views, improving image quality and diagnostic accuracy.

The VX1 is a cardiac mapping software tool designed to assist clinicians during atrial fibrillation or atrial tachycardia procedures by analyzing 3D anatomical and electrical maps of the heart's atria. Using machine and deep learning algorithms, it identifies complex dispersed electrograms in real-time to help guide electrophysiologists in annotating areas of interest, potentially improving mapping accuracy during catheter ablation procedures.

The Vivid T8 and Vivid T9 are advanced ultrasound imaging systems designed primarily for cardiac imaging but also applicable to vascular and general radiology. These systems provide high-quality ultrasound imaging with various transducer options and include AI-based features that assist clinicians by semi-automating measurements and recognizing Doppler spectra. They support multiple clinical applications in hospital and private settings and enhance diagnostic accuracy and efficiency through AI integration.

The Vivid iq is a high-performance compact diagnostic ultrasound system made by GE Medical Systems Ultrasound. It supports a wide range of clinical applications including cardiovascular, abdominal, fetal, musculoskeletal, and more. The system enables automatic AI-based cardiac measurements and spectrum recognition to assist clinicians in analysis and diagnosis. It is intended for use by trained healthcare professionals in hospitals and private medical offices.

TOMTEC-ARENA is a clinical software package designed for reviewing, quantifying, and reporting medical imaging data primarily related to cardiovascular, fetal, and abdominal structures. It helps clinicians assess structures and functions from various imaging modalities in multiple dimensions, facilitating disease diagnosis through detailed quantifications and advanced visualization tools.

The Vivid E80, Vivid E90, and Vivid E95 are advanced diagnostic ultrasound systems specialized for cardiac imaging but also capable of vascular and general radiology applications. Featuring AI-driven tools for cardiac image analysis, these systems enable clinicians to perform automated measurements and enhanced visualization to improve efficiency and reduce variability. They support various clinical settings including hospitals and private offices with a range of imaging modes and transducers.