FDA Radiology AI Devices

The Stereotaxic Guiding Surgical Device, NaoTrac S, is a robotic system designed to assist neurosurgeons in accurately positioning and guiding surgical instruments during stereotactic neurosurgical procedures. By using preoperative MRI or CT images for planning and intraoperative guidance, it helps surgeons precisely target brain regions for biopsies, electrode placement, or other interventions, improving surgical accuracy and patient safety.

ClearPoint System (Software Version 2.2) is a medical software device designed to assist clinicians during neurological procedures by providing MRI-guided stereotactic guidance for the placement and operation of instruments like biopsy needles or deep brain stimulation leads. It integrates advanced automatic segmentation and visualization of brain structures from MRI scans, enhancing planning and intraoperative navigation. This helps improve surgical accuracy and patient outcomes in brain interventions.