FDA Radiology AI Devices

Customize is a prescription-use software tool designed to assist clinicians in planning ankle arthroplasty surgeries. It uses CT and X-ray images to generate 3D models and helps visualize and modify surgical treatment plans. The software incorporates AI to segment anatomical structures, improving preoperative planning and communication of treatment options.

Transpara 1.7.2 is an AI-based software tool that helps radiologists detect and assess suspicious regions in breast mammography and tomosynthesis exams. It highlights potential cancerous lesions, scores their likelihood of malignancy, and provides an overall exam score to assist in clinical decision making, enhancing the accuracy and efficiency of breast cancer screening.

ABMD Software is an AI-powered application that measures bone mineral density from existing CT scans by analyzing the trabecular region of vertebral bones. It assists clinicians by providing retrospective assessment of bone density without the need for additional dedicated scans, thereby avoiding extra radiation exposure. It supports healthcare providers by offering BMD, Z-scores, and T-scores for evaluation, serving as a supplementary diagnostic tool rather than replacing standard DXA scans.

Deep Learning Image Reconstruction by GE Healthcare is a software solution that uses a specialized deep neural network to reconstruct high-quality CT images from raw X-ray data. It produces images with less noise and improved image quality while maintaining low radiation dose. It supports head, whole body, cardiac, and vascular CT scans, helping clinicians obtain clearer images for diagnosis.

The Swoop Portable MR Imaging System by Hyperfine, Inc. is a bedside portable MRI device designed to produce internal head images using magnetic resonance imaging. It allows clinicians to perform imaging at the point of care when full diagnostic exams are not practical. Its AI-enabled reconstruction algorithm enhances image quality by reducing noise and blurring for multiple MRI sequences, helping physicians with diagnosis.

cvi42 Auto Imaging Software Application is an AI-powered medical imaging software designed to assist clinicians in evaluating cardiovascular MR and CT images. It uses machine learning to semi-automatically contour cardiac structures, perform calcium scoring, and analyze coronary arteries, aiding in diagnosis and quantitative assessment of heart and vessel conditions.

DeepRhythmAI is a cloud-based AI software that automatically analyzes two-lead ECG data to detect cardiac arrhythmias. It supports healthcare professionals by providing analysis results that need to be reviewed and confirmed. It is designed for integration into other medical devices or software platforms and assists clinicians in identifying rhythm issues in adult patients.

Viz SDH is an AI-driven software designed to analyze non-contrast CT scans of the head to detect subdural hemorrhages. It provides rapid notifications of suspected cases to neurovascular or neurosurgical specialists through a mobile application, improving workflow efficiency and potentially expediting patient care decisions. The system does not replace diagnostic evaluation but serves as a parallel workflow triage tool to alert specialists early.

The Vivid E80, Vivid E90, and Vivid E95 are advanced diagnostic ultrasound systems designed primarily for cardiac imaging but also applicable to vascular and general radiology. These systems use ultrasound technology to capture, process, and analyze images of the human body, aiding clinicians in precise measurements and display of ultrasound data. They include features such as 3D imaging, Doppler modes, and AI-assisted tools like Easy Auto EF and Easy AFI LV for enhanced image analysis, improving workflow and diagnostic accuracy for healthcare professionals.

EchoPAC Software Only / EchoPAC Plug-in is a software platform designed for diagnostic review, analysis, and reporting of ultrasound images. It allows post-processing of raw data from GE ultrasound scanners and DICOM ultrasound images, supporting multiple clinical applications like fetal, cardiac, abdominal, and musculoskeletal imaging. The software helps clinicians manage patient records and generate detailed reports efficiently.