FDA Radiology AI Devices

The Navient Image Guided Navigation System (ENT) by ClaroNav is a surgical navigation tool designed to help ENT surgeons accurately locate anatomical structures by using preoperative CT and MR imaging combined with real-time optical tracking. It assists in planning and navigation during various ENT procedures, improving surgical precision and safety.

ICS Dizcovery (1091) is a portable video-oculography system designed as goggles with built-in cameras and motion sensors to track eye and head movements simultaneously. It is used to assess vestibular-ocular reflex and nystagmus in patients experiencing dizziness, vertigo, or balance disorders. The system connects to software that analyzes the collected eye movement data to aid clinicians in diagnosing vestibular conditions.

The MONARCH™ Platform is a robotic bronchoscopy system that provides physicians with precise, image-guided navigation and visualization of patient airways. It integrates electromagnetic tracking with real-time video from a flexible bronchoscope and can optionally update navigation using live imaging from Cone Beam CT scans. This aids clinicians in diagnosing and treating lung conditions with improved accuracy and control.

ENT EM is a surgical navigation system designed to assist surgeons during ear, nose, and throat procedures by providing real-time guidance using electromagnetic tracking. It integrates with patient imaging data from multiple modalities to accurately localize instruments and anatomical structures, improving surgical precision and safety. The device includes an AI/ML-based algorithm to aid in the registration step by automatically detecting anatomical landmarks, streamlining the planning and navigation process.