Cranial Navigation, Navigation Software Cranial, Navigation Software Craniofacial, Cranial EM System, Automatic Registration iMRI
Description
Cranial EM is intended as an image-guided planning and navigation system to enable neurosurgery procedures. The device is indicated for any medical condition in which a reference to a rigid anatomical structure can be identified relative to images (Computed Tomography (CT), Computed Tomography Angiography (CTA), X-Ray, MR, Magnetic Resonance Angiography (MRA) and ultrasound) of the anatomy.
Detailed example
Cranial Navigation is an image guided surgery system for navigated treatments in the field of cranial surgery, including the newly added Craniofacial indication. It offers different patient image registration methods and instrument calibration to allow surgical navigation by using optical tracking technology. The device provides different workflows guiding the user through preoperative and intraoperative steps. Automatic Registration iMRI is an accessory to Cranial Navigation, enabling automatic image registration for intraoperatively acquired MR imaging. The registration object can be used in subsequent applications (e.g. Cranial Navigation 4.1). It consists of the software Automatic Registration iMRI 1.0, a registration matrix, and a reference adapter. Similarly, the Cranial EM System is an image-guided planning and navigation system to enable neurosurgical procedures. It offers instrument handling as well as patient registration to allow surgical navigation by using electromagnetic tracking technology.
AI / analytics pattern
Computer Vision: AI that processes and interprets visual data (e.g., images and videos).
Automation level / stage
c) Deployed – The use case is being actively authorized or utilized to support the functions or mission of an agency.
Expected benefit
Support neurosurgery planning.
Controls / human review
ATO: Not reported; PIA: Not published