FDA Radiology AI Devices

Sim&Size is a medical imaging software designed to help clinicians visualize cerebral blood vessels and simulate the placement and sizing of neurovascular implantable devices for preoperative planning. It uses 3D images from rotational angiography to provide 3D reconstructions, automatic vessel segmentation, and tools for sizing and positioning implantable devices, supporting better planning of neurovascular interventions and surgeries.

Anterion is a non-contact ophthalmic imaging device that uses swept-source optical coherence tomography (SS-OCT) to visualize and measure the anterior segment of the eye, including corneal thickness, anterior chamber parameters, lens thickness, and axial length. It helps clinicians by providing detailed tomographic images and quantitative metrics critical for diagnosis and surgical planning, such as cataract surgery. The device includes multiple software applications for imaging and analysis and uses AI-powered processing for precise measurements, improving clinical decision-making and patient management.

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.

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.

The V5 and H5 series diagnostic ultrasound systems from Samsung Medison are advanced ultrasound imaging devices that provide real-time images and Doppler analysis to assist healthcare professionals in clinical diagnosis across a broad range of applications including obstetrics, cardiology, musculoskeletal, and dermatology. These systems use AI-powered tools for tasks like view recognition, segmentation, and measurement, enhancing accuracy and efficiency in ultrasound examinations.

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.

Cercare Medical Neurosuite (CMN) Capillary Function with Virtual Expert is a software tool designed to assist trained medical professionals by providing advanced image processing and analysis of MRI and CT scans, specifically for brain perfusion and diffusion imaging. It helps visualize hemodynamic properties and tissue characteristics important for managing conditions like acute stroke by automatically identifying regions of interest and calculating volumetric and perfusion parameters, improving diagnostic and treatment decision workflows for clinicians.

SyMRI is a software tool that processes MRI data to generate detailed maps of brain tissue properties and volumetric measurements. It enables visualization of multiple image contrasts from a single MRI scan and allows clinicians to adjust image contrasts after acquisition. This helps in better diagnosis and understanding of brain health by providing comprehensive and quantifiable tissue information.

CDM Insights is a software tool that helps trained healthcare practitioners analyze brain MRI scans of adults over 45 years old. It automatically segments and quantifies brain structures and white matter hyperintensities, compares findings with normative data from healthy populations, and provides easy-to-understand visual and numerical reports. This aids clinicians in evaluating neurological conditions more accurately and efficiently.