FDA Radiology AI Devices

AI-Rad Companion (Pulmonary) is AI-powered software that analyzes chest CT scans to help radiologists and clinicians identify and measure lung structures and lesions. It segments lungs and lung lobes, detects lung nodules, compares current images to prior scans for lesion follow-up, and quantifies pulmonary density. These features support the clinical assessment and monitoring of lung diseases, improving workflow efficiency and diagnostic accuracy.

ClearPoint Maestro Brain Model is a software tool that uses AI to automatically identify, label, and measure the volume and shape of various brain structures from MRI scans. This helps clinicians by simplifying and speeding up the process of brain image analysis, supporting diagnosis and treatment planning in neurological conditions.

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.

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.

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.

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.

AI4CMR v1.0 is a software tool that uses artificial intelligence to automatically analyze cardiac MRI scans to measure cardiac function parameters like ventricle volumes and ejection fraction. It helps clinicians by providing automated quantification of cardiac metrics from MR images, improving workflow efficiency and supporting clinical decisions when integrated into a DICOM viewer.

Libby Echo:Prio is a software tool that processes DICOM-compliant cardiac ultrasound images to provide automated measurements and analysis of cardiac function, such as ejection fraction and heart rate. It supports cardiologists and sonographers by automating view classification, border segmentation, and generating quantification reports, thus aiding clinical decision-making in cardiac care.

BrainInsight is a software product from Hyperfine, Inc. that automatically processes low-field MR brain images to label, segment, and measure brain structures. It provides physicians with annotated images, color overlays, and reports that help in evaluating brain anatomy and pathology more efficiently. The system is cloud-based and integrates with FDA-cleared PACS systems to seamlessly assist clinical workflows.

The Vivid T8 and Vivid T9 are advanced diagnostic ultrasound systems designed primarily for cardiac imaging but also supporting vascular and general radiology applications. They provide digital acquisition, processing, analysis, and image display, and incorporate AI algorithms such as Easy Auto EF and Easy AFI LV that assist clinicians by automating measurements and analysis of cardiac function, improving workflow and diagnostic accuracy.