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.

The Navient Image Guide Navigation System is a computerized surgical navigation system designed to assist surgeons in precisely locating anatomical structures during neurosurgical procedures. It helps surgeons plan and navigate in real time using CT or MR images, improving accuracy and safety in cranial operations such as tumor resection and biopsies.

The Alignment System Cranial by Brainlab AG is an image guided surgical system designed to assist neurosurgeons in planning and precisely guiding surgical instruments during cranial stereotactic procedures such as biopsy of intracranial lesions, placement of stereoelectroencephalography (SEEG) electrodes, and laser interstitial thermal therapy (LITT). It uses optical tracking technology and specialized software to continuously track instrument positions relative to patient anatomy on pre- or intraoperative images, helping clinicians achieve accurate trajectories to improve procedural safety and effectiveness.

The ClearPoint System (Software Version 3.0) is a software platform that assists neurosurgeons by providing precise stereotactic guidance during neurological procedures such as biopsies and deep brain stimulation lead placements. It integrates with MR and CT imaging to automatically identify and segment brain structures and hardware components, improving procedure planning and monitoring. This system enhances the clinician's ability to accurately navigate and operate within the brain, supporting safer and more effective interventions.

The Geniant Cranial is a navigated neurosurgical positioning robot designed to assist neurosurgeons in accurately locating anatomical structures and guiding surgical instruments during neurosurgical procedures. It uses preoperative CT or MR images to create 3D models and tracks surgical tools in real-time, helping surgeons plan and follow surgical routes more precisely, thereby improving surgical outcomes and safety.

The FLASH EVD System is a stereotactic image-guided navigation tool designed to assist surgeons in the precise placement of external ventricular drain catheters during neurosurgery. It uses preoperative imaging and real-time tracking to improve accuracy and workflow during procedures that relieve intracranial pressure. This helps surgeons position instruments more accurately without rigidly fixing the patient or instruments.

The Zeta Cranial Navigation System is a stereotaxic image guidance system designed to help neurosurgeons spatially position and orient surgical instruments during cranial surgery. It uses 3D preoperative CT or MRI scans to assist in real-time navigation without requiring rigid fixation of the patient. This system enhances the precision of neurosurgical procedures by providing visual guidance based on medical imaging data.

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.

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.

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.