FDA Radiology AI Devices

The Remex Spine Surgery Navigation Instrument is designed to assist surgeons in precisely positioning surgical tools and spinal implants during spinal surgeries. It works by integrating fluoroscopic and CT images to guide procedures like pedicle screw placement, enhancing surgical accuracy and patient safety.

The TECHFIT DISRP® System is a digital surgery platform designed to help clinicians plan and simulate maxillofacial surgeries. It processes CT scan data to create 3D models and surgical guides or splints that assist surgeons during operations by translating imaging information into physical tools for improved surgical precision and patient-specific treatment.

BriefCase-Triage by Aidoc Medical, Ltd. is an artificial intelligence software that analyzes CT scans including the ribs to identify suspected acute rib fractures. It alerts clinicians with notification and preview images to help prioritize cases for faster review, aiding workflow triage without altering original images or serving as a diagnostic tool. This helps radiologists address urgent findings more efficiently.

IRISeg is a software application developed by Intuitive Surgical that utilizes machine learning to assist with the segmentation of contrast-enhanced kidney CT scans and generates 3D models for preoperative surgical planning and intraoperative display. It provides both automatic and manual tools to segment kidney structures, helping clinicians visualize anatomy more efficiently and accurately for better patient management.

AutoContour (Model RADAC V4) by Radformation, Inc. is a software tool designed to automatically contour anatomical structures on CT and MR images to aid radiation treatment planning. Using machine learning, it helps clinicians create accurate contours of organs and tissues, streamlining the preparation process for radiation therapy and improving planning precision.

DrAid™ for Liver Segmentation is a web-based AI software that assists healthcare professionals in analyzing liver images from CT scans. It generates semi-automated liver segmentation and allows physicians to manually refine these segmentations and identify lesions, aiding in evaluation and treatment planning without providing direct diagnosis.

The EFAI Neurosuite CT Midline Shift Assessment System (MLS-CT-100) is an AI-powered software tool that analyzes non-contrast head CT images to identify signs of midline shift. It assists radiologists by flagging cases that may need urgent attention, helping prioritize patient care without altering original images or making direct diagnostic decisions.

ClearRead CT CAC is software that helps physicians assess coronary artery calcification on non-contrast, non-gated chest CT scans. It automatically detects and quantifies calcified coronary lesions, providing an Agatston score and categorization to aid in cardiovascular risk assessment. This allows clinicians to efficiently obtain quantitative calcium scoring to help guide patient management, supplementing but not replacing clinical expert review.

RadUnity (Version 1.0.0) is a software device designed to centralize, manage, standardize, and network CT images using the DICOM protocol. It reformats CT medical images according to user-defined preferences to ensure consistent image formatting, thus supporting qualified radiology professionals in preparing images for interpretation. It is not intended for primary diagnostic review nor for mammographic image interpretation.

BriefCase-Quantification is an AI-based software that analyzes contrast-enhanced CT scans to measure aortic diameters at key anatomical landmarks, helping clinicians assess normal and aneurysmal aortas. It processes CT images in a cloud environment, produces measurement results for review, and is intended to assist but not replace radiologist evaluations.