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.

Al-Rad Companion (Pulmonary) is an AI-powered software by Siemens that processes CT images of the lungs to assist clinicians in quantitatively and qualitatively analyzing lung diseases. It segments lungs and lobes, detects lung lesions and areas of abnormal tissue density, and provides measurements to support radiologists and physicians in emergency, specialty, and general care settings. This helps streamline and improve lung disease evaluation.

The AHI System is a software tool that helps healthcare professionals monitor adult patients' cardiovascular status by analyzing ECG signals to detect signs of current hemodynamic instability and predict future episodes. It provides continuous updates and color-coded alerts for clinicians to increase vigilance and improve patient care.

The Vantage Fortian 1.5T, MRT-1550, V8.0 with AiCE Reconstruction Processing Unit for MR is a 1.5 Tesla MRI system that produces detailed cross-sectional images of the body or head. It incorporates AI-based reconstruction and machine learning technologies to enhance image quality and assist in planning scans, improving diagnostic accuracy and patient comfort.

MammoScreen 2.0 is an AI-based software tool designed to assist physicians by automatically analyzing standard screening mammograms including FFDM and DBT images. It marks suspicious soft tissue lesions or calcifications on breast images and provides a level of suspicion score to help radiologists improve detection and characterization of breast cancer findings. This tool acts as a concurrent reading aid to improve diagnostic accuracy but does not replace physician judgment.

EndoScreener is a computer-assisted detection software that automatically identifies and highlights potential polyps during colonoscopy procedures. It processes the live video feed from the colonoscope and overlays blue boxes on suspected polyps, alerting the physician in real-time to improve polyp detection and assist clinical decision-making during colonoscopy in adults.

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.

Soteria.AI is an image-intensified fluoroscopic x-ray system designed for use in a variety of radiographic and fluoroscopic applications including cardiac, vascular, general diagnostic, and interventional imaging. It helps reduce patient and operator radiation exposure by automatically providing a region of interest using AI technology, thereby improving safety during imaging procedures.

The Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) System by Hyperfine, Inc. is a portable MRI device designed to provide bedside imaging of the brain. It uses advanced deep learning for image reconstruction to reduce noise and blurring, enabling clinicians to view internal head structures more clearly. This system facilitates quicker and more accessible brain imaging in various care settings, aiding in diagnosis without the need to transport patients to traditional MRI suites.

Lunit INSIGHT MMG is an AI-powered computer-assisted detection and diagnosis software designed to help radiologists detect, localize, and characterize suspicious areas for breast cancer on mammograms. It works as an adjunct tool viewed after the initial physician read, providing visual marks and scores indicating the likelihood of malignancy to assist clinical decision-making and improve breast cancer detection during mammography screenings.