FDA Radiology AI Devices

Quantib Prostate is an AI-powered image post-processing software designed to assist medical professionals in analyzing prostate MRI scans. It provides tools for visualization, semi-automatic segmentation of prostate anatomy and lesions, volume computations, and PI-RADS scoring support to facilitate the interpretation of prostate MR studies, aiding clinical decision-making.

Saige-Dx is an AI-based software that analyzes digital breast tomosynthesis mammograms to detect suspicious soft tissue lesions and calcifications that may indicate cancer. It provides radiologists with a suspicion level for each finding and the entire case, helping improve detection accuracy and reduce reading time during breast cancer screening.

The Versana Balance by GE Medical Systems is a general-purpose diagnostic ultrasound system intended for use by trained healthcare professionals. It offers various imaging modes including B-mode, Doppler, 3D/4D imaging, and elastography. The device assists clinicians by providing high-quality ultrasound images and includes AI features such as Whizz Label for anatomy identification, helping in image interpretation and workflow efficiency. It is designed for use in hospitals and clinics across a broad range of clinical applications including abdominal, cardiac, obstetrics, gynecology, vascular and musculoskeletal imaging.

Overjet Caries Assist is an AI-powered software that helps dentists detect and outline tooth decay on bitewing dental X-ray images. It automatically identifies possible caries areas, providing visual annotations to assist dentists in diagnosis and treatment planning. This tool supports dental professionals by improving caries detection sensitivity while allowing them to review and adjust annotations, enhancing diagnostic accuracy without replacing clinical judgment.

Segment 3DPrint is a medical software developed by Medviso AB that helps clinicians review and segment images from medical scanners to generate detailed 3D models. These models assist doctors with visualization, measuring, and treatment planning, particularly in orthopaedic, maxillofacial, and cardiovascular fields. The software also supports creating physical 3D printed replicas from these models, enhancing clinical workflows and patient care.

MVision AI Segmentation is a software device designed to automatically create segmentation templates of anatomical regions on CT images to assist clinicians in radiation therapy treatment planning. It uses machine learning-based algorithms to generate initial contours for multiple anatomical sites, which clinicians can review and modify before use, helping to save time and improve efficiency in clinical workflows.

Oxehealth Vital Signs is a software medical device that uses video footage from fixed-installation cameras to noninvasively measure pulse rate and estimated breathing rate through analysis of chest wall movements. It is designed for use in single occupancy rooms within hospitals and secured environments where healthcare professionals periodically monitor patients. This technology enables spot checks of vital signs without physical contact, supporting clinical monitoring while minimizing patient disturbance and infection risk.

aPROMISE X is a software platform for healthcare professionals and researchers that assists in accepting, transferring, storing, manipulating, quantifying, and reporting digital medical images from PSMA PET/CT scans. It allows users to visualize multiple scans, mark regions of interest, and perform quantitative analysis to help identify suspicious lesions in oncology cases, improving clinical efficiency and consistency.

The MAGNETOM Lumina and MAGNETOM Vida Fit with syngo MR XA50A are advanced MRI diagnostic systems that produce detailed cross-sectional images and spectra of the head, body, or extremities. The device uses sophisticated MRI pulse sequences and integrates deep learning-based reconstruction algorithms to produce high-quality images quickly and reliably, aiding physicians in diagnosis and in planning interventional procedures.

The EFAI RTSuite CT HN-Segmentation System is AI-powered software designed to assist radiation oncology professionals by automatically contouring organs at risk in head and neck CT images. It helps streamline radiation therapy treatment planning by providing initial segmentations that clinicians review and edit, improving workflow efficiency and accuracy.