FDA Radiology AI Devices

Eclipse II with Smart Noise Cancellation is software that improves digital X-ray images by reducing noise using advanced AI technology. It enhances images acquired with digital radiography systems, helping radiologists see clearer images for better diagnosis of adult and pediatric patients, excluding mammography.

The syngo.CT Lung CAD by Siemens Healthcare GmbH is a software tool designed to assist radiologists in detecting solid and subsolid lung nodules on chest CT scans. It uses advanced AI algorithms based on convolutional neural networks to highlight suspicious areas, reducing the chance of missed nodules. The software integrates with existing medical imaging platforms, improving clinicians' efficiency and accuracy in lung nodule detection, a critical task in lung cancer screening and diagnosis.

Oxehealth Vital Signs is a software device that analyzes video images captured by standard cameras to noninvasively measure a patient's pulse rate and estimated breathing rate. It uses proprietary algorithms to monitor skin pixel intensity changes and chest wall movements, allowing healthcare staff to perform vital sign spot checks without disturbing the patient. This is especially useful in hospital or secured environments where minimizing patient contact is advantageous.

Viz ICH is an AI-powered software tool that analyzes non-contrast CT brain images to detect suspected intracranial hemorrhages. It sends notifications to neurovascular or neurosurgical specialists to facilitate earlier patient review and intervention. The software is integrated with a mobile application for previewing images and managing notifications, though image previewing is non-diagnostic and full diagnosis relies on standard clinical evaluation.

ProFound AI Software V3.0 is an AI-based medical imaging software that aids radiologists by detecting and highlighting suspicious soft tissue densities and calcifications in 3D digital breast tomosynthesis images. It provides confidence scores that help clinicians identify potentially malignant findings more quickly and accurately during breast cancer screening and diagnosis.

NinesMeasure is a software tool designed to help trained radiologists measure the size of pulmonary nodules on adult thoracic CT scans. It uses artificial intelligence to automatically calculate long and short axis diameters of nodules, providing quantitative information for better assessment and tracking over time. This tool assists clinicians by streamlining nodule measurement, though it is not intended to replace full patient evaluation or diagnosis.

The LVivo Software Application is an AI-powered tool that automates the analysis of ultrasound images, specifically echocardiograms, to measure cardiac functions such as left and right ventricular function and bladder volume. It helps clinicians accurately and efficiently assess heart structure and function in patients, supporting better diagnosis and management of heart conditions.

HepaFat-AI is an AI-powered software that automatically analyzes MRI images of the liver to measure liver fat content. It helps clinicians assess fatty liver disease, monitor liver fat in patients undergoing weight loss, and screen liver transplant donors by providing quantitative and reproducible fat fraction results quickly without manual input.

Genius AI Detection is an AI software designed to assist radiologists by automatically identifying potential abnormalities such as masses and calcifications in digital breast tomosynthesis exams. It highlights suspicious regions on breast images, provides confidence scores, and helps improve diagnostic accuracy and workflow efficiency for breast cancer screening and diagnosis.

AView LCS by Coreline Soft Co., Ltd. is a medical software tool that helps clinicians review, analyze, and report on thoracic CT scans. It automatically detects and measures lung nodules, calculates malignancy risk, supports follow-ups with nodule matching, and generates diagnostic reports. This improves the accuracy and efficiency of lung nodule assessment and lung cancer screening.