FDA Radiology AI Devices

Constellation (CON-001) is an automated software tool that processes whole-body MRI images to segment anatomical regions and quantify various tissues such as muscles, fat, and organs. It provides clinicians with detailed quantitative reports with visual overlays to support clinical decisions without making autonomous diagnoses, focusing on healthy adult patients.

NeuroQuant is an automated software device designed to help clinicians by providing automatic labeling, visualization, and volumetric measurement of brain structures and lesions from MRI scans. It enhances clinical workflow by delivering segmented images and morphometric reports that can be reviewed and compared to normative data, aiding in diagnosis and monitoring of neurological conditions.

CoLumbo is a software tool that helps radiologists and spine surgeons analyze MRI images of the lumbar spine by automatically segmenting anatomical features and measuring spine structures. It identifies out-of-range measurements and assists users in documenting findings, streamlining the review and reporting process without making any medical diagnosis.

OptimMRI (v2) is a software application that processes MRI brain images to generate detailed 3D annotated models highlighting specific brain regions. It helps clinicians in planning neurosurgical procedures by localizing critical brain nuclei, thus supporting accurate functional planning and improving surgical outcomes.

The i2Contour by MRIMath LLC is a web-based AI-assisted software designed to semi-automatically segment and quantify glioblastoma tumors from MRI scans. It helps trained medical professionals by providing initial tumor contours which can be reviewed and manually adjusted, enabling accurate tumor volume assessments for patients with pathologically confirmed glioblastoma. This facilitates monitoring tumor progression or treatment response but is not intended for primary diagnosis.

SubtleSYNTH (1.x) is an AI-based software that synthesizes STIR contrast images from T1- and T2-weighted spine MRI sequences. It uses a convolutional neural network to generate synthetic images that can be reviewed alongside traditional MRI scans, helping radiologists by providing additional image contrast information without additional scanning time or patient burden.

Medihub Prostate is a semi-automatic image processing software designed for analyzing prostate MR images. It uses AI to outline the prostate region semi-automatically and supports radiologists and urologists in reviewing MR data. The software requires user editing and confirmation, enhancing the accuracy of prostate volume measurements and analysis, aiding clinical decision-making without replacing the expert's judgment.

The SIS System by Surgical Information Sciences, Inc. is an advanced software tool that assists clinicians, including surgeons, neurologists, and radiologists, by providing detailed visualization and 3D models of specific brain structures. It uses machine learning models trained on high-resolution MR images to aid in planning and guiding deep brain stimulation surgeries and other neurological procedures, helping to precisely locate key brain areas and implanted leads for improved surgical outcomes.

uOmnispace.MR is advanced software developed by Shanghai United Imaging Healthcare Co., Ltd. that helps clinicians view, process, and analyze magnetic resonance (MR) images across various clinical applications such as brain, breast, cardiac, vascular, and neurological imaging. It supports interpretation and evaluation by providing tools for stitching, dynamic studies, spectroscopy, perfusion, vessel analysis, cardiac function analysis, and flow analysis, enabling improved diagnostic workflows and patient care.

BoneMRI is an AI-powered software that enhances MRI images to better visualize bone structures in the pelvic and spine regions. It improves the contrast of bone relative to soft tissue to assist radiologists and orthopedic surgeons in assessing bone morphology and tissue radiodensity without replacing CT imaging. It supports clinical use in patients aged 12 and older and operates via hospital networks, ensuring data security.