FDA Radiology AI Devices

The XIDF-AWS801 Angio Workstation (Alphenix Workstation), V9.5, by Canon Medical Systems is a medical imaging system used alongside interventional angiography equipment. It provides 2D and 3D imaging to assist clinicians in visualizing blood vessels throughout the body during catheter procedures. The device incorporates AI deep learning software to improve the detection and stabilization of stent markers, enhancing image clarity and aiding in diagnosis and treatment planning.

DeepXray is an AI-powered software that helps medical professionals analyze knee X-rays by automatically measuring joint space width and assessing signs of osteoarthritis such as sclerosis, joint space narrowing, and osteophytes. It supports clinicians by providing detailed grading based on established radiographic criteria and offers an interactive report for review and editing before finalizing.

The FaceHeart Vitals Software Development Kit (FH vitals SDK) is an AI-based software that measures pulse rate from facial video streams using standard cameras on mobile devices or computers. It provides non-invasive, real-time pulse rate monitoring for adults at rest, intended to assist healthcare professionals but not to replace critical care or continuous monitoring. The SDK uses face recognition and signal processing algorithms to produce accurate pulse rate measurements, helping clinicians monitor patient heart rate remotely or in general healthcare settings.

VisiRad XR is an AI-powered software that helps physicians detect suspicious lung nodules and masses on chest X-rays by marking regions of interest. It acts as a second reader to assist radiologists in their interpretations, enhancing diagnostic accuracy for adult patients in outpatient or emergency settings.

Spine Planning 2.0 is a software tool that helps surgeons plan spinal surgeries using medical images like CT, MR, and X-rays. It uses AI to automatically label vertebrae and suggest spinal implants such as screws and rods, improving accuracy and efficiency during preoperative and intraoperative planning.

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.

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.

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.

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.

syngo.CT Lung CAD (Version VD30) is a computer-aided detection tool developed by Siemens Healthcare GmbH to help radiologists identify solid and subsolid pulmonary nodules in chest CT scans. The software highlights regions that might be overlooked, improving the accuracy and efficiency of lung nodule detection during radiological review. It can operate as a first or second reader and includes a mode to filter out subsolid and fully calcified nodules for focused analysis.