Geniant Cranial (Navigated Neurosurgical Positioning Robot)
Koh Young Technology Inc.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.
Intended Use
The device is intended to aid in locating anatomical structures and for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons for navigating and guiding compatible surgical instruments in open or percutaneous procedures. It is indicated for any neurosurgical procedure in which stereotactic neurosurgery may be appropriate and where reference to a rigid anatomical structure, such as the skull, can be identified relative to anatomy images.
Technology
Geniant Cranial is a hardware platform combining a robot arm with optical markers, probes, a head frame, and application software. It reprocesses CT or MR images, displays them in multiple fluoroscopic views, allows creation of surgical routes and 3D anatomical models, and tracks instrument positions in real-time to guide surgery.
Performance
Non-clinical performance testing demonstrated a 3D positional accuracy with a mean error ≤ 1.5 mm and trajectory angle accuracy ≤ 2.0 degrees. Testing considered all components and worst-case clinical scenarios, confirming substantial equivalence in accuracy and safety to predicate devices.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
5/10/2024
8 months - 2
FDA Approval
1/17/2025
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