FDA Radiology AI Devices

MAGENTIQ-COLO (ME-APDS) is a computer-aided detection system used alongside standard white-light colonoscopy videos to help endoscopists identify suspicious regions indicative of polyps. It processes live video frames using AI to highlight possible lesions during colonoscopy, aiming to improve detection rates and assist clinicians in real-time without replacing clinical judgement or histopathological diagnosis.

The Nicolet EDX is a diagnostic system by Natus Neurology Incorporated that helps healthcare providers measure electrical activity in nerves and muscles through tests like nerve conduction studies, electromyography, and evoked potentials. It assists clinicians in assessing nervous system function, locating neural structures during surgery, and supporting diagnosis of neuromuscular conditions by recording and analyzing electrophysiological signals.

The Aurora system is a hybrid medical imaging device combining nuclear medicine (SPECT) and computed tomography (CT) technologies to help healthcare professionals detect, diagnose, and monitor diseases such as cardiovascular disorders, neurological conditions, and cancer. It enhances images using advanced acquisition, gating, and software features, improving evaluation and patient care across a variety of clinical applications.

The Geniant Cranial is a navigated neurosurgical positioning robot designed to assist neurosurgeons in accurately locating anatomical structures and guiding surgical instruments during neurosurgical procedures. It uses preoperative CT or MR images to create 3D models and tracks surgical tools in real-time, helping surgeons plan and follow surgical routes more precisely, thereby improving surgical outcomes and safety.

The Affera Integrated Mapping System is a software and hardware system designed to help cardiologists map the heart's electrical activity during catheter-based procedures. It uses magnetic and electromagnetic tracking to visualize catheters inside the heart in real time, records electrical signals from the heart, and displays 3D cardiac maps. This assists clinicians in diagnosing and treating heart rhythm disorders with improved accuracy and guidance.

SpectoMed (v1.0) is a software tool for medical professionals that enables real-time 3D visualization and analysis of CT and MRI images. It supports virtual and augmented reality interfaces to aid clinicians in preoperative planning and during surgery by providing realistic spatial views of patient anatomy along with measurement tools, enhancing diagnostic assessment and surgical preparation.

PeriCALM Patterns 3.0 is an AI-based software tool designed to assist clinicians in monitoring fetal well-being during pregnancy and labor. It analyzes fetal heart rate and uterine contraction signals, automatically identifying patterns such as accelerations, decelerations, baseline heart rate, and contractions. This information supports clinical decision-making for pregnant patients at or beyond 32 weeks of gestation by providing annotated summaries of the fetal monitor recordings.

FullFocus is a web-based software that enables pathologists to view, navigate, and manage digital images of scanned surgical pathology slides prepared from FFPE tissue. It helps pathologists review images for primary diagnosis by providing tools like zooming, panning, measurement, and annotation, improving diagnostic workflow and accuracy.

The 8MP Color LCD Displays (models C811W, C811WT, PA27, PA27T) are high-resolution color LCD screens designed to display digital images of histopathology slides for primary diagnosis. They aid pathologists by providing stable, calibrated, and precise image visualization from validated whole-slide imaging systems, assisting in the interpretation of digital pathology images.

The FLASH EVD System is a stereotactic image-guided navigation tool designed to assist surgeons in the precise placement of external ventricular drain catheters during neurosurgery. It uses preoperative imaging and real-time tracking to improve accuracy and workflow during procedures that relieve intracranial pressure. This helps surgeons position instruments more accurately without rigidly fixing the patient or instruments.