FDA Radiology AI Devices

Alignment System Cranial by Brainlab AG is a surgical navigation system designed to assist surgeons during cranial stereotactic procedures such as biopsies of intracranial lesions and placement of stereo-electroencephalography electrodes. It integrates optical tracking with advanced software and hardware to precisely guide surgical instruments, improving accuracy and safety. The system includes artificial intelligence features that aid in patient registration processes by detecting anatomical landmarks, enhancing surgical planning and execution.

Spine Planning 2.0 is a software tool that helps surgeons plan spinal surgeries using medical images like CT, MR, and X-rays. It uses AI to automatically label vertebrae and suggest spinal implants such as screws and rods, improving accuracy and efficiency during preoperative and intraoperative planning.

The Cranial Navigation and Cranial EM System by Brainlab AG is an image-guided surgical navigation system designed to assist surgeons during cranial and craniofacial procedures. It uses imaging data like CT, MR, X-Ray, and ultrasound to track surgical instruments relative to patient anatomy. The system integrates artificial intelligence via machine learning algorithms to detect brain abnormalities and anatomical landmarks in MR images to enhance registration accuracy and view centering, helping surgeons perform more precise navigation in complex brain surgeries.

Brainlab Elements is a suite of software applications that process and analyze medical image data from various modalities to assist clinicians in planning surgeries and radiation treatments. It offers tools for image registration (fusion), segmentation (contouring), diffusion tensor imaging (fibertracking), blood oxygen level dependent MRI analysis (BOLD MRI mapping), and cerebrovascular image fusion (Image Fusion Angio). These capabilities help improve precision and understanding of patient anatomy and function during clinical procedures.

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.

Brainlab Elements Trajectory Planning (2.6) is a software designed to help neurosurgeons plan the best paths for surgical instruments during cranial procedures, such as electrode placements or biopsies. It uses anatomical images from scans to plan and guide minimally invasive or open surgeries, enhancing precision and improving patient outcomes.