FDA Radiology AI Devices

FlightPlan for Embolization by GE Medical Systems SCS is a software application that processes 3D X-ray angiography images to help clinicians visualize blood vessels during the planning phase of embolization procedures. It uses AI-powered algorithms to automatically segment vasculature and define root points, assisting physicians in better treatment planning. This enhances clinical decision-making but is not intended for use during the delivery of therapy itself.

AccuContour is a software for radiation oncology departments that uses AI-based deep learning to automatically register multi-modality medical images and segment non-contrast CT images. It assists clinicians in treatment planning, evaluation, and adaptation by generating critical imaging information, thus improving workflow efficiency and patient care in radiation therapy.

Spectral Bone Marrow is an automated deep learning-based software designed for spectral CT images of the body and extremities. It segments bone regions and creates enhanced, color-coded images to help radiologists better visualize bone marrow. This assists in diagnosing traumatic and non-traumatic bone conditions more efficiently by providing improved image visualization and an automated clinical workflow.

The V8 and V7 Diagnostic Ultrasound Systems by Samsung Medison are advanced ultrasound machines designed for a wide range of clinical applications including fetal, abdominal, musculoskeletal, cardiac, and more. They use various ultrasound imaging modes and AI-based tools to assist healthcare professionals in acquiring and analyzing ultrasound images for improved diagnosis and workflow efficiency.

Clarius AI is software integrated with the Clarius Ultrasound Scanner that uses artificial intelligence to semi-automatically measure tendon thickness on ultrasound images of musculoskeletal structures such as the Achilles’ tendon and patellar tendon. It helps healthcare professionals by segmenting ultrasound images and automatically placing measurement calipers, streamlining the quantification process while allowing manual adjustment by trained clinicians.

TruPlan Computed Tomography (CT) Imaging Software is designed to help clinicians visualize and measure the left atrial appendage and surrounding heart structures from CT scans. It supports pre-procedural planning and post-procedural evaluation of the left atrial appendage closure (LAAC) procedure by providing segmentation, image visualization, and measurement tools. Machine learning enhances segmentation and landing zone detection for improved workflow. The software aids in clinical decision-making but does not replace existing standard care procedures.

MR Diffusion Perfusion Mismatch V1.0 by Olea Medical is an AI-powered software tool that automatically processes MR Diffusion and Perfusion imaging data to compute parametric maps, extract volume metrics, and calculate mismatch volumes. It assists radiologists and surgeons by providing quantitative imaging data that supports clinical decision-making. The software integrates with medical image platforms to streamline workflow without altering the original images and is intended to be used alongside other clinical information, not as a standalone diagnostic tool.

AVIEW is a medical imaging software by Coreline Soft that helps clinicians analyze CT scans of the lungs and heart. It automatically segments lung structures, characterizes lung nodules with detailed measurements, and provides calcium scoring of coronary arteries to assess cardiovascular risk. It integrates with AI-based CAD tools and offers cloud and mobile access, making it easier and faster for doctors to diagnose lung and heart conditions.

BrainInsight is an automated software that processes low-field MRI brain images to provide automatic labeling, spatial measurement, and volumetric quantification of brain structures. It produces annotated and segmented brain images with color overlays and detailed reports, helping clinicians assess brain anatomy and abnormalities efficiently, particularly using low-field MRIs.

The Avenda Health AI Prostate Cancer Planning Software is an AI-driven tool that assists physicians by segmenting prostate MR images, evaluating and quantifying lesions, and planning diagnostic or interventional procedures such as biopsies or tissue ablation. It provides a cancer probability map and confidence scores to help clinicians accurately characterize prostate cancer lesions, improving workflow efficiency and decision making in prostate cancer care.