Cranial Navigation, Navigation Software Cranial, Navigation Software Craniofacial, Cranial EM System, Automatic Registration iMRI

Overview

Development stage

DeployedSource: c) Deployed – The use case is being actively authorized or utilized to support the functions or mission of an agency.

High-impact designation

High-impactSource: a) High-impact

Impact justification

Not reported

Start date

Not reported

Withheld from public reporting

Not reported

Mission

Topic area

Health and Medical

Operational functions

Clinical and medical Derived by keyword rules; see methodology

Problem the AI is intended to solve

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.

Expected benefits

Support neurosurgery planning.

System outputs

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.

Technology

AI classification

Computer visionSource: Computer Vision: AI that processes and interprets visual data (e.g., images and videos).

System name(s)

Not reported

Custom-developed code

No

Public source code

Not reported

Sourcing

How it was built

Purchased from vendorSource: a) Purchased from a vendor

Vendor (as reported)

Not reported

Vendors (standardized)

None on the standard list

A vendor is the supplier named by the agency. It does not identify the underlying model or AI technology.

Data and privacy

Involves PII

Not reported

Privacy Impact Assessment

Not reported

Authorization to Operate

Not reported

Demographic features

Not reported

Training and evaluation data

Not reported

Federal Data Catalog

Not reported

Governance

0 of 8 minimum-practice questions answered. A blank answer means the agency reported nothing; it does not mean the practice is absent.

Potential impacts and how they were identified

Not reported