FDA Radiology AI Devices

Viz ICH is an AI-based software tool designed to analyze non-contrast CT scans of the brain for signs of intracranial hemorrhage (ICH). When the software detects suspected ICH, it sends notifications to neurovascular or neurosurgical specialists, helping speed up patient care by alerting clinicians early. The system includes a backend server for image processing and a mobile app for reviewing images in a non-diagnostic way for quick assessment and communication.

Al-Rad Companion (Musculoskeletal) is AI-powered software designed to analyze CT images of the spine. It supports clinicians by automatically segmenting and labeling vertebrae, measuring vertebral heights, and calculating the mean Hounsfield unit values within vertebrae, aiding in musculoskeletal disease evaluation and assessment.

The SonoVision Ultrasound Imaging System is a general-purpose ultrasound device designed to help physicians visualize nerves, vascular structures, and other anatomical features, especially during spinal procedures. It uses a specialized ultrasound probe and advanced image processing software to provide real-time imaging assistance, enhancing the accuracy and safety of medical interventions.

syngo.CT Lung CAD is an AI-powered software tool that helps radiologists detect solid pulmonary nodules in chest CT scans. Acting as a second reader, it alerts clinicians to potential nodules that might have been overlooked during their initial review, thereby improving diagnostic accuracy and patient care.

The Vantage Galan 3T with AiCE Reconstruction Processing Unit is a 3 Tesla MRI system from Canon that uses deep convolutional neural networks to reduce thermal noise and improve image quality in MRI scans, particularly for brain and knee regions. This advanced software and hardware combination helps clinicians obtain clearer MRI images, enhancing diagnosis without increasing scan time or contrast use.

Transpara is an AI-powered software designed to assist physicians in interpreting full-field digital mammography and digital breast tomosynthesis exams. It highlights suspicious regions that may indicate breast cancer, providing scores that indicate the likelihood of malignancy. This helps radiologists improve detection accuracy and workflow efficiency while supporting clinical decisions during breast cancer screening.

Broncholab is a software tool that helps doctors analyze CT scans of the lungs by providing detailed quantitative information about lung volume, airway volume, lung density, and other pulmonary tissue characteristics. It assists in the diagnosis and follow-up of lung abnormalities by creating 3D models and measurements from CT images, supporting clinical decision-making.

AccuContour is a standalone software designed for radiation oncology departments. It uses AI-based deep learning to automatically contour organs at risk on non-contrast CT images and to register multimodality medical images. This helps clinicians in treatment planning, evaluation, and adaptation, improving workflow efficiency and accuracy in radiation therapy.

icobrain-ctp is a software package designed to analyze CT perfusion scans of the brain. It processes imaging data to calculate brain tissue perfusion parameters and volumes affected by abnormalities, providing detailed reports to aid clinicians in stroke and brain blood flow assessment. The tool supports image export in DICOM format and integrates with standard radiological viewing platforms, helping healthcare professionals make informed decisions efficiently.

The Behold.ai Red Dot device is an AI-powered software platform that assists radiologists by automatically analyzing adult chest X-ray images to identify suspected pneumothorax cases. It integrates into clinical workflows by notifying radiologists through PACS or workstation systems to prioritize these cases for faster review. It is intended to support, but not replace, clinical decision-making.