FDA Radiology AI Devices

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.

The Caption Interpretation Automated Ejection Fraction Software uses AI to analyze transthoracic cardiac ultrasound images and automatically estimate the left ventricular ejection fraction. This helps clinicians in cardiac evaluations by providing a consistent and efficient measurement of heart function, aiding diagnosis and treatment decisions.

The Vivid S60N and Vivid S70N are advanced general-purpose ultrasound imaging systems by GE Healthcare, specialized for cardiac imaging but also supporting a broad range of diagnostic ultrasound applications across the human body. These systems facilitate ultrasound imaging, measurement, display, and analysis to assist physicians in clinical environments such as hospitals and private offices, enhancing diagnostic accuracy and workflow efficiency through digital acquisition, processing, and semi-automated AI-based measurement features.

LVivo Software Application is an AI-powered ultrasound image analysis platform that automatically calculates important medical parameters related to cardiac and bladder function. It helps clinicians assess heart ventricles and bladder volume using processed ultrasound images, thereby improving diagnostic efficiency and accuracy.

MEDO ARIA is a cloud-based medical imaging software that uses machine learning to help clinicians view, quantify, and generate reports from ultrasound images of infant hips. It supports diagnosis of developmental hip dysplasia (DDH) in newborns and infants up to 12 months, assisting radiologists by automating some image analysis tasks and improving workflow efficiency.

The Auto 3D Bladder Volume Tool by Butterfly Network is a software application integrated with Butterfly Network ultrasound systems. It uses machine learning (U-Net convolutional neural network) to automatically segment and measure bladder volume from ultrasound images, providing clinicians with noninvasive quantitative data to support diagnosis in adult patients.

QLAB Advanced Quantification Software is a software application that assists clinicians by providing advanced tools to view and quantify ultrasound image data, specifically for cardiac assessment including mitral valve quantification, helping improve diagnosis and treatment planning.

This product group from Philips Ultrasound, Inc. includes several series of diagnostic ultrasound systems and software that produce and analyze ultrasound images to assist clinicians in diagnosing various conditions. They support 2D, Doppler, and advanced imaging modes for applications across many body regions, improving clinical workflow and diagnostic confidence.

Caption Guidance is an AI-powered software that assists healthcare professionals in acquiring high-quality cardiac ultrasound images. It provides real-time feedback and guidance similar to an expert sonographer, helping to capture standard echocardiographic views accurately and efficiently during 2D transthoracic echocardiography.

KOSMOS is a handheld diagnostic ultrasound system by EchoNous, Inc. that integrates ultrasound imaging, electrocardiogram (ECG), and digital auscultation in one device. It is designed for clinical assessment of cardiac, pulmonary, abdominal, and vascular systems by providing synchronized images, sounds, and waveforms. This facilitates enhanced diagnosis and guided interventions for healthcare professionals in various clinical settings.