FDA Radiology AI Devices

HealthFLD is an AI-powered software that analyzes CT images of the liver to provide clinicians with quantitative and qualitative measurements of liver attenuation, aiding the assessment of fatty liver disease. It processes both non-contrast and contrast CT scans for adult patients and outputs liver density metrics to support clinical decision-making.

Clarius Bladder AI is a software application integrated into the Clarius Ultrasound Scanner system that uses artificial intelligence to assist healthcare professionals in semi-automatically measuring bladder volume using ultrasound images. It automates bladder detection and measurement in both sagittal and transverse views but allows users to manually adjust results, facilitating efficient and accurate bladder volume assessment in adult patients.

BriefCase-Quantification is an AI-powered radiological image management and processing software that analyzes contrast-enhanced CT images to measure the maximum axial diameter of the abdominal aorta. It assists trained medical specialists by providing preliminary measurements to help evaluate normal and aneurysmal abdominal aortas. The tool outputs annotated preview images, which serve as unofficial measurements to aid clinical review, with final decisions left to radiologists.

MeVis Liver Suite is a medical image analysis software designed to assist physicians, especially radiologists and surgeons, in evaluating the liver and its vascular anatomy using CT and MR images. It provides tools for manual and AI-based semi-automatic segmentation of abdominal organs, liver lesions, and vascular structures, supporting treatment planning and follow-up assessment for liver-related conditions. The software calculates volumes, visualizes 3D vascular tumor margins, and enables manual spatial registration of images, enhancing clinical workflow without replacing diagnostic workstations.

VisAble.IO is a software tool that helps doctors plan and confirm liver ablation procedures using CT images. It provides features like segmentation of liver structures, virtual placement of ablation needles, and analysis of ablation zones to support clinicians during treatment. It is designed to improve the accuracy and efficiency of liver ablation therapy planning and evaluation in clinical settings.

HepaFatSmart (V2.0.0) is an automated AI-assisted software that analyzes magnetic resonance imaging (MRI) datasets to measure liver fat quantitatively. It calculates volumetric liver fat fraction (VLFF), proton density fat fraction (PDFF), and steatosis grading without user input, supporting clinical diagnosis and management of fatty liver disease and screening of liver transplant donors. This software helps clinicians by providing consistent, reproducible liver fat measurements from MRI scans, aiding patient care in liver-related conditions.

Velacur is a portable ultrasound device that measures the stiffness and attenuation of liver tissue by generating and analyzing shear waves using ultrasound imaging. It incorporates AI-based algorithms to assist clinicians in assessing liver disease by providing detailed tissue characterization, enhancing accuracy and ease of use at the point of care in clinics and hospitals.

Viz AAA is an AI-powered software device designed to analyze CT angiogram images of the abdomen to detect suspected abdominal aortic aneurysms. It helps specialists prioritize patient studies by flagging those with potential aneurysms, improving workflow efficiency in clinical settings. The software provides non-diagnostic preview images and emphasizes that diagnostic decisions remain with treating specialists.

BriefCase by Aidoc Medical, Ltd. is an AI-powered software that assists radiologists by automatically analyzing chest and abdominal CT scans to detect and flag suspected vertebral compression fractures. It helps prioritize medical images for review, enabling faster triage without altering original images or workflows, thus improving the efficiency of radiological diagnosis and patient care.

LiverMultiScan v5 is software that helps clinicians assess liver health by analyzing MRI scans to generate detailed images and quantitative maps of liver tissue properties such as fat content, iron concentration, and T1 relaxation times. It aids doctors in diagnosis by providing automated liver segmentation and measurements that enhance non-invasive liver assessment.