FDA Radiology AI Devices

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.

The Precision AI Surgical Planning System (PAI-SPS) is a software and hardware system designed to assist surgeons in preoperative planning and intraoperative guidance for shoulder replacement surgeries. It creates a 3D model of the patient's shoulder joint from CT scans, allowing surgeons to visualize and plan implant placement precisely. Custom surgical guides are also produced to help accurately position shoulder implant components during surgery, enhancing surgical outcomes.

AI Platform 2.0 (AIP002) by Exo Imaging is an AI-powered software tool designed to assist healthcare professionals by analyzing ultrasound images of the heart and lungs. It helps detect lung structures and artifacts, and quantifies cardiac functions such as left ventricular ejection fraction and myocardium wall thickness. The tool also provides real-time quality feedback to improve ultrasound image acquisition, aiding clinicians in making better diagnostic assessments for adult patients.

AISAP Cardio V1.0 is an AI-powered software that analyzes cardiac point-of-care ultrasound images to detect and assess valvular pathologies like regurgitations and stenosis, and measures key cardiac functions such as ejection fraction and chamber sizes. It supports physicians by generating diagnostic reports that aid in interpreting ultrasound images, improving accuracy and efficiency in evaluating heart conditions in adult patients.

CardIQ Suite is a non-invasive software tool that analyses 2D and 3D CT cardiac images to assist clinicians in visualizing and measuring heart structures and vessels. It provides calcium scoring to evaluate calcified plaques and uses deep learning algorithms to automate segmentation and labeling of heart and coronary arteries, improving diagnostic workflow for cardiovascular diseases.

MammoScreen 3 is an artificial intelligence software tool designed to assist physicians in interpreting screening mammograms from digital mammography and digital breast tomosynthesis systems. It provides graphical marks indicating suspicious soft-tissue lesions or calcifications, along with a suspicion score and lesion characterization, helping radiologists in their diagnosis and reporting. The software is intended as an aid to, but not a replacement for, the physician's clinical judgment.

CADDIE is a cloud-based AI software that helps gastroenterologists detect suspected colorectal polyps during colonoscopy procedures by analyzing live video from endoscopy. It highlights potential lesions with visual markers to aid clinical decision-making, improving polyp detection without replacing the physician's judgment.

The ACUSON Sequoia Diagnostic Ultrasound System family by Siemens Medical Solutions includes multi-purpose, software-controlled ultrasound systems designed to provide detailed images and measurements from inside the body. These systems support various clinical applications including fetal, abdominal, cardiac, musculoskeletal, and vascular imaging, among others. They assist clinicians by offering advanced imaging modes such as 2D, Doppler, elastography, and 3D/4D volume imaging, as well as specialized tools like Ultrasonically-Derived Fat Fraction (UDFF) for managing hepatic steatosis. The systems deliver real-time imaging and measurements to help diagnose and manage a wide range of conditions effectively.

Rayvolve by AZmed SAS is an AI-powered software designed to assist radiologists and emergency physicians in detecting fractures from X-ray images of various musculoskeletal regions in adults and children aged 2 years and older. It enhances fracture diagnosis by automatically highlighting potential fractures on standard radiographic views, improving diagnostic accuracy and workflow efficiency.