FDA Radiology AI Devices

MySegmenter (v2.0.0) is a medical imaging software that converts CT and MRI scans into 3D anatomical models for surgical planning and educational use, specifically in orthopedic and craniomaxillofacial cases. It helps clinicians visualize and prepare for surgeries by creating accurate, patient-specific 3D models, though it is not intended for use in the operating room.

The Medyssey Navigation System is a reusable surgical instrument set designed to work with the Medtronic StealthStation navigation system. It helps surgeons precisely locate anatomical structures during spinal surgeries by integrating with imaging data such as CT or MR-based models, fluoroscopy images, or digitized landmarks. This improves accuracy in placing spinal fixation implants and supports open or minimally invasive procedures.

The Atlas Stim Headbox by Neuralynx, Inc. is a medical device intended for cortical or intracranial stimulation during EEG examinations, such as stereo EEG (SEEG). It works as an accessory to the ATLAS Neurophysiology System, enabling controlled electrical stimulation of the brain using third-party electrodes and recording the brain's electrical responses. This device assists neurosurgeons and neurologists in mapping brain function, especially in complex cases requiring precise neural stimulation.

Merge Universal Viewer (MUV) is a software application that provides healthcare professionals internet access to view, analyze, and share medical images from multiple imaging modalities. It supports diagnostic workflows by enabling display and manipulation of radiological images, and can output digital files for 3D printing. The viewer facilitates image review, reporting, and data sharing, thus improving accessibility and efficiency in radiology departments.

OTOPLAN is software that helps otologists and neurotologists visualize, segment, and analyze medical images such as CT and MRI scans to assist in planning and assessing ear-related surgical procedures like cochlear implantation. It provides tools for 3D reconstruction, electrode visualization, and image fusion, enhancing surgical planning accuracy and patient outcomes.

The FUJIFILM Processor EP-8000 and Endoscope Model EG-860R form a combined endoscopic video imaging system used in gastroenterology. The EP-8000 processor provides illumination with LED light sources and advanced image processing techniques to enhance visualization, while the EG-860R endoscope enables detailed examination and endoscopic treatment of the upper digestive tract. This system assists clinicians in diagnosing and treating conditions in the esophagus, stomach, and duodenum by delivering high-quality images and supporting multiple enhanced imaging modes.

Oncospace is a software tool designed to help radiation oncologists and dosimetrists plan cancer treatments more efficiently. It uses machine learning to predict dose objectives for organs at risk based on patient anatomy, assists in setting up treatment protocols, and integrates with treatment planning systems to optimize and review radiotherapy plans. This helps clinicians design safer and more effective radiation schedules for patients with cancers in various body regions.

NEAT 001 is a software medical device that automatically analyzes EEG data obtained during sleep studies to detect different stages of sleep according to established sleep medicine guidelines. It helps clinicians by providing automated scoring and visualization of sleep stages, improving the efficiency and consistency of sleep evaluations in adult patients.

autoSCORE V2.0 is an AI-based software that helps medical professionals review EEG recordings by identifying and classifying sections indicating brain abnormalities such as epileptiform and non-epileptiform activities. It assists neurologists by marking likely abnormal EEG segments, providing probabilities for specific abnormality types, thereby enhancing the efficiency and accuracy of EEG interpretation without replacing clinical judgment.

Tyto Insights for Rhonchi Detection is an AI-enabled software system that helps healthcare professionals detect abnormal lung sounds known as rhonchi from lung sound recordings. The system processes audio recorded using a compatible FDA-cleared digital stethoscope and provides decision support to clinicians in evaluating lung health, aiding in diagnosis and treatment decisions.