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.

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.