FDA Radiology AI Devices

The Rapid Aneurysm Triage and Notification device by iSchemaView Inc. is an AI-powered software designed to analyze CT angiography images of the head to detect suspected saccular aneurysms. It helps hospital networks and radiologists by prioritizing cases with potential aneurysms for faster review, improving workflow in routine patient care. The software provides notifications and compressed preview images for informational use, supporting radiologists in triage but not intended for diagnosis.

Brainomix 360 Triage ICH is a software tool that uses artificial intelligence to analyze non-contrast brain CT images in acute settings to detect suspected intracranial hemorrhages. It notifies specialists promptly to prioritize patient care and improve workflow efficiency by providing timely alerts via mobile and web applications. It supports clinicians by assisting triage but does not replace diagnostic evaluation.

The uMI Panorama is a PET/CT system that provides combined metabolic and anatomical imaging to assist healthcare professionals in detecting, diagnosing, staging, and managing various diseases including oncology, cardiology, and neurology conditions. It supports both PET and standalone CT imaging and can be used for low dose CT lung cancer screening, enhancing patient care with fused functional and anatomical images.

The Global Hypoperfusion Index (GHI) Algorithm is a software tool used on compatible advanced monitoring platforms to predict the risk of a global hypoperfusion event in surgical or non-surgical patients. It analyzes physiological data to provide clinicians with early warning of potential hemodynamic instability, helping to anticipate and manage patient deterioration in critical care settings.

Sonio Detect is a software tool that uses machine learning to help healthcare professionals during fetal ultrasound exams by automatically detecting views, anatomical structures, and verifying the quality of images in real-time. This supports sonographers and fetal specialists to ensure comprehensive and high-quality ultrasound examinations for fetuses from 11 to 37 weeks gestational age.

ME-APDS (Magentiq Eye’s Automatic Polyp Detection System) is an AI-powered software system that assists endoscopists during colonoscopy by automatically detecting and highlighting polyps and other mucosal abnormalities in real-time video images captured by standard white-light endoscopy. It runs on video output from standard colonoscopy equipment to enhance lesion detection, improving the accuracy and efficiency of colorectal screening and surveillance. It helps clinicians by providing visual prompts of suspected polyps, enabling timely clinical actions while functioning as an adjunct tool.

ANDI is a software tool that processes diffusion-weighted MRI brain scans to create 3D maps of white matter tracts. It helps neurologists and radiologists by providing detailed visualization and measurements of brain white matter structures, serving as an adjunct tool for patient assessment without making diagnoses.

UltraSight AI Guidance is a mobile AI-based application that helps non-expert medical professionals acquire high-quality cardiac ultrasound images by providing real-time guidance on how to position and manipulate the ultrasound probe for standard transthoracic echocardiography views. It enhances image acquisition quality and enables better diagnosis even by novice users.

OptimMRI is a software tool that helps medical professionals analyze pre-operative brain MRI images by generating 3D annotated models. It supports neurosurgical planning by localizing key brain regions, helping doctors visualize and plan treatments more precisely.

The Cranial Navigation and Cranial EM System by Brainlab AG is an image-guided surgical navigation system designed to assist surgeons during cranial and craniofacial procedures. It uses imaging data like CT, MR, X-Ray, and ultrasound to track surgical instruments relative to patient anatomy. The system integrates artificial intelligence via machine learning algorithms to detect brain abnormalities and anatomical landmarks in MR images to enhance registration accuracy and view centering, helping surgeons perform more precise navigation in complex brain surgeries.