FDA Radiology AI Devices

AVIEW LCS by Coreline Soft Co., Ltd. is a diagnostic software tool that reviews, analyzes, and reports on thoracic CT images to help clinicians characterize lung nodules. It automatically measures nodule size, volume, density, and growth over time, integrates with FDA-cleared CAD for nodule detection, and provides lung cancer risk scoring and standardized Lung-RADS categorization. This helps clinicians detect, monitor, and manage lung nodules more accurately and efficiently.

The uMR 780 is a 3.0 Tesla MRI system designed to generate high-quality cross-sectional and spectroscopic images of the head, body, and extremities. It assists clinicians in diagnosing various conditions by providing detailed anatomical and functional images, with the option to use contrast agents. The latest version includes software enhancements such as new pulse sequences and AI-assisted image reconstruction methods, improving image quality and analysis.

This product group from Philips Ultrasound, Inc. includes several series of diagnostic ultrasound systems and software that produce and analyze ultrasound images to assist clinicians in diagnosing various conditions. They support 2D, Doppler, and advanced imaging modes for applications across many body regions, improving clinical workflow and diagnostic confidence.

NinesAI is a software tool that uses artificial intelligence to automatically analyze head CT images for signs of intracranial hemorrhage and mass effect. It helps prioritize critical cases by notifying radiologists of potential emergencies to assist in timely and effective patient care. The software works alongside standard workflows and does not replace full clinical evaluation or diagnosis.

Caption Guidance is an AI-powered software that assists healthcare professionals in acquiring high-quality cardiac ultrasound images. It provides real-time feedback and guidance similar to an expert sonographer, helping to capture standard echocardiographic views accurately and efficiently during 2D transthoracic echocardiography.

CuraRad-ICH is an AI-powered software that helps radiologists quickly identify and prioritize head CT scans that may show acute intracranial hemorrhage (bleeding in the brain). By automatically analyzing CT images, it assists in faster diagnosis and treatment decisions to improve patient outcomes.

The SIGNA Premier by GE Healthcare is a whole-body magnetic resonance imaging (MRI) system designed to produce high-resolution diagnostic images of many body parts including the head, spine, joints, and heart. It incorporates a new AI-powered software feature called AIR Recon DL that improves image quality by enhancing signal-to-noise ratio and sharpness, while allowing for shorter scan times. This helps clinicians get clearer images faster, supporting better diagnosis and patient care.

AIMI-Triage CXR PTX by RADLogics is an FDA-cleared AI software that helps hospital radiologists prioritize adult chest X-rays that might show moderate to large pneumothorax. It analyzes chest X-rays and flags urgent cases for quicker review, improving workflow and patient care by notifying radiologists of possible urgent findings without replacing full diagnosis.

Rapid ICH is an AI-powered clinical software tool designed to help hospital radiology workflows by automatically analyzing non-contrast head CT scans to detect suspected intracranial hemorrhage. It provides alerts and compressed preview images to clinicians through PACS, email, and a mobile app to prioritize urgent cases and aid timely diagnosis and treatment decisions.

KOSMOS is a handheld diagnostic ultrasound system by EchoNous, Inc. that integrates ultrasound imaging, electrocardiogram (ECG), and digital auscultation in one device. It is designed for clinical assessment of cardiac, pulmonary, abdominal, and vascular systems by providing synchronized images, sounds, and waveforms. This facilitates enhanced diagnosis and guided interventions for healthcare professionals in various clinical settings.