FDA Radiology AI Devices

VIDA|vision is an interactive imaging software that helps physicians analyze CT scans of the lungs. It uses deep learning algorithms to automatically segment lung regions and provides detailed quantitative analyses to assist in diagnosing and monitoring lung diseases such as lung cancer, COPD, and asthma. This software reconstructs two-dimensional CT images into 3D views and generates detailed reports, streamlining the workflow and reducing manual effort for clinicians.

HYPER DLR is a software-only device that applies a pre-trained convolutional neural network to reduce noise in fluorodeoxyglucose (FDG) PET images. It improves image quality by distinguishing and removing noise components while preserving image details, aiding radiologists and nuclear medicine physicians in better image interpretation.

AI-Rad Companion Prostate MR is AI-powered image analysis software designed to assist radiologists in viewing, segmenting, and analyzing prostate MR images to support targeted MR-US fusion biopsies. It automates prostate gland segmentation, allows manual annotation of findings, calculates PSA density, and exports results for biopsy planning, improving workflow and biopsy accuracy for clinicians.

FractureDetect (FX) is an AI-powered software that analyzes X-ray images of bones to help doctors detect fractures. It highlights areas on radiographs where fractures are detected, improving accuracy and efficiency in diagnosis for various bone regions in adults.

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.

HealthMammo is an AI-enabled software tool designed to analyze 2D full-field digital mammograms to identify and flag suspicious findings. It assists radiologists by prioritizing mammogram cases in the PACS/worklist, helping clinicians review critical cases faster and improve workflow efficiency without replacing diagnostic evaluation.

The Vantage Orian 1.5T with AiCE Reconstruction Processing Unit for MR is a 1.5 Tesla MRI system from Canon that enhances image quality by using AI-powered noise reduction techniques. This advanced software algorithm uses deep learning to reduce thermal noise and improve signal clarity, especially in brain and knee imaging, helping clinicians obtain clearer and more diagnostically useful MRI images.

AI-Rad Companion Engine is a software platform that supports visualization and post-processing of medical images for diagnostic use, helping clinicians by facilitating measurement, analysis, and data management. It integrates with multiple imaging modalities and PACS systems, providing an interface to add additional AI-driven clinical processing extensions.