FDA Radiology AI Devices

LVivo Seamless is an AI-powered software application that analyzes ultrasound (echocardiogram) images to automatically detect heart structures, measure ejection fraction (EF), and calculate global longitudinal strain (GLS), aiding clinicians in assessing cardiac function efficiently and accurately. It runs offline on a server in healthcare settings, accepts DICOM-format ultrasound clips from various vendors, and sends results to PACS for professional review.

OnQ Neuro is an automated software device designed to analyze neurological MRI images, specifically for brain tumors. It performs automatic segmentation and quantification of tumor volumes and diffusion-weighted imaging data, helping clinicians assess tumor progression and treatment response more efficiently by providing quantitative and graphical image data that can be integrated into clinical workflows.

Critical Care Suite with Endotracheal Tube Positioning AI Algorithm is a software tool that uses AI to automatically analyze frontal chest X-rays. It detects and localizes the position of an endotracheal tube and calculates the distance between the tube tip and the carina, providing clinicians with important information on tube placement to improve patient care.

ClariSIGMAM is a software tool designed to automatically analyze digital mammograms to estimate breast density by calculating the ratio of fibroglandular tissue to the total breast area. It categorizes breast density using BI-RADS groups to assist radiologists in assessing breast tissue composition, providing adjunctive information to support interpretation but is not a diagnostic aid.

AmCAD-UT is a Windows-based AI-assisted software designed to help clinicians analyze thyroid ultrasound images. After initial review by a physician, the software quantifies and visualizes sonographic features of thyroid nodules, specifically those larger than 1cm, aiding in clinical decision-making for biopsy recommendations. It facilitates detailed image analysis and generates automated reports to support thyroid cancer diagnosis and management.

breastscape v1.0 is an advanced software tool used with Olea Sphere 3.0 to assist breast imaging physicians and MRI technologists in analyzing breast MRI data. It provides visualization, semi-automatic lesion segmentation, kinetic curve analysis, and planning assistance for MR-guided breast biopsy procedures, helping clinicians detect and characterize breast lesions and plan interventions more effectively.

qER-Quant is an AI-powered software that processes non-contrast head CT scans to automatically identify and quantify key brain structures such as intracranial hyperdensities, lateral ventricles, and midline shift. It helps clinicians by providing volumetric data and visual overlays to aid in diagnosis and monitoring brain conditions over time.

Us2.v1 is an AI-powered software platform that automatically processes and analyzes transthoracic cardiac ultrasound images to measure key cardiac structural and functional parameters. It helps cardiologists and healthcare providers by producing comprehensive reports to support clinical decision-making for adult patients.

Change Healthcare Anatomical AI is a standalone software that uses AI algorithms to analyze CT and MR images, automatically identifying anatomical regions and creating detailed anatomic descriptors. This information helps clinicians and integrated healthcare systems quickly locate and categorize relevant images or studies without altering the original images.

PowerLook Density Assessment V4.0 is a software tool that analyzes synthetic 2D images from digital breast tomosynthesis exams to provide breast density categories using the ACR BI-RADS 5th Edition. This helps radiologists assess breast tissue composition as an adjunctive aid, improving breast cancer screening processes.