FlightPlan for Embolization

Interventional Radiology Neurosurgery Vascular Surgery

Contact for pricing
Regulatory Status Disclosed

Overview

FlightPlan for Embolization by GE Medical Systems SCS is an advanced software application designed to assist clinicians in the planning phase of embolization procedures. It processes 3D X-ray angiography images, specifically Cone Beam CT (CBCT) scans, to help physicians visualize complex vasculature. The tool utilizes AI-powered algorithms for automatic segmentation of blood vessels and definition of root points, which enhances clinical decision-making. It operates on GE HealthCare’s interventional X-ray systems and Advantage Workstation (AW) platforms, serving as an adjunct means to help visualize vasculature. The software is intended for use during the planning phase and is not for therapy delivery. It allows for the export of user-defined data for potential use during the guidance phase of the procedure.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Processes 3D X-ray angiography (CBCT) images
  • AI-powered automatic vessel segmentation
  • Automatic root point definition
  • Assists in visualizing vasculature for embolization planning
  • Adjunct tool for clinical decision-making
  • Operates on GE HealthCare interventional X-ray systems and Advantage Workstation platforms
  • Exports user-defined data for procedure guidance
  • Semi-automatic segmentation and selective display of vasculature
  • Identification of points of interest
  • Potential integration with Innova Vision for 3D roadmap overlay on live fluoroscopy

Use Cases

  • Planning phase of embolization procedures
  • Analysis of complex 3D X-ray angiography images
  • Visualization of complex tumor vascularization (e.g., liver embolization)
  • Identification of tumor-feeding vessels
  • Selection of embolization injection points
  • Assisting catheter guidance during embolization procedures

What Physicians Need to Know

AI Model Architecture (deep learning approach)
FlightPlan for Embolization with the AI Segmentation option utilizes deep learning-based algorithms for automatic segmentation of vasculature and automatic definition of the root point. [11] This AI Segmentation option was developed from modifications to the predicate device, GE HealthCare's FlightPlan for Embolization [K193261]. [11] The deep learning-based Liver Segmentation algorithm performs an automated segmentation of the entire liver on injected CBCT acquisitions. [7] The outputted liver segmentation is an intermediate result that is used as a boundary for the Virtual Parenchyma Visualization. [7] GE HealthCare is leveraging deep learning across its portfolio to train image reconstruction algorithms. [17]
Supported Modalities (CT/MRI/X-ray/US)
FlightPlan for Embolization is a post-processing, software-only application that uses 3D X-ray angiography images (CBCT) as input. [11] It processes 3D X-ray angiography images (CBCT) acquired from GE HealthCare's interventional X-ray system. [11] The software operates on GE HealthCare's Advantage Workstation (AW) platform and AW Server platform. [11]
FDA Clearance Pathway (510k/De Novo)
FlightPlan for Embolization received FDA clearance via the 510(k) pathway. [11] The AI Segmentation option for FlightPlan for Embolization triggered a 510(k) submission (K223490). [11] The predicate device for this submission was GE HealthCare's FlightPlan for Embolization [K193261]. [11] FlightPlan for Liver, a related tool, also received FDA clearance in 2012. [1, 4]
DICOM Support & Standards
FlightPlan for Embolization complies with NEMA PS 3.1 - 3.20 Digital Imaging and Communications in Medicine (DICOM) Set (Radiology) standard. [11] GE Healthcare's Volume Viewer, which FlightPlan for Embolization extends, uses DICOM images to reconstruct 3D volumes. [10] The views displayed can be saved in DICOM format (Secondary Capture or modality reformatted images). [10] GE is actively involved in the development of the DICOM v3.0 Standard. [12]
Sensitivity & Specificity Data
For FlightPlan for Liver, a related application, studies showed improved sensitivity and accuracy in detecting tumor-feeding vessels compared to standard DSA analysis. [6, 14, 15] One study reported that FlightPlan for Liver improved the sensitivity of tumor-feeding vessel identification to up to 97%. [6] The sensitivity of FlightPlan for Liver in different segmentation sensitivity groups (D, L, H) ranged from 92.7% to 99.1%, compared to DSA at 85.3%. [14, 15] Specificity, positive predictive value, negative predictive value, and accuracy were also higher for FlightPlan for Liver across all segmentation sensitivity groups compared to DSA. [14, 15] Reader agreement for identification of liver tumor feeding vessels using FlightPlan for Liver was significantly higher than for either DSA or CBCT alone. [6]
RSNA/ACR Validation
GE Healthcare announced FDA clearance for FlightPlan for Liver at RSNA 2012. [1, 4]
Reading Room Workflow Impact
FlightPlan for Embolization is intended to be used during the planning phase of embolization procedures. [11] It helps clinicians visualize vasculature to aid in the planning of endovascular embolization procedures. [11] The software helps interventionalists plan their embolization procedures by highlighting vessels traveling from the catheter to the lesion's vicinity. [1, 4] This can be used as a 3D roadmap superimposed on live fluoroscopic images to guide catheter placement. [1, 4] This solution aims to simplify intricate embolization procedures and extend the technique to more practitioners by improving confidence in performing difficult procedures. [1, 4]
Physician Tip

FlightPlan for Embolization is a planning tool and its output should be used as an adjunct means to visualize vasculature. [7, 11] The injection points should be confirmed independently of FlightPlan for Embolization prior to therapy delivery. [11] Manual adjustment of segmentation sensitivity can improve the accuracy of tumor-feeding vessel identification, particularly for small hepatocellular carcinoma (HCC). [14, 15]

FlightPlan for Embolization is part of the Embo ASSIST solution and requires an AW workstation with Vision 2, VesselIQ Xpress, and Autobone Xpress. [2, 5, 8] It operates on GE HealthCare's Advantage Workstation (AW) platform and AW Server platform, and is an extension to the GE HealthCare's Volume Viewer application. [11] User-defined data from the 3D X-ray angiography images may be exported for use during the guidance phase of the procedure. [11] The software can save results and export them to GE's Vision application for 3D road-mapping. [7]

Details

Category Radiology & Imaging AI, Surgical AI
Pricing Contact for pricing
DeploymentOn-premise (software-only application on GE HealthCare workstations and X-ray systems)
Compliance
BAA Available Yes AI-estimated
HIPAA Compliant Yes AI-estimated
FDA Status Cleared AI-estimated
Integrations
EHR Not specified
Specialties Interventional Radiology, Neurosurgery, Vascular Surgery

What the Web Says

FlightPlan for Embolization is a post-processing software package from GE Healthcare designed to assist physicians in analyzing 3D X-ray angiography images and planning embolization procedures. It helps visualize vasculature and select embolization injection points, and has been noted for its ability to clarify feeding vessels for tumors and aid in surgical resections. The software is part of GE Healthcare's Embo ASSIST AI solution and requires an AW workstation with specific applications like Volume Viewer.

Overall: Positive

Strengths

  • Helps physicians visualize and analyze 3D X-ray angiography images for embolization planning.
  • Aids in the selection of embolization injection points.
  • Can clarify feeding vessels for tumors, which traditional imaging may miss.
  • Assists in surgical resections with minimal bleeding and nerve damage by clearly identifying blood supply sources.
  • Offers high-resolution images for detailed vision and real-time guidance for accuracy.
  • Includes AI Segmentation option for enhanced analysis.

Limitations

  • Not intended for use during therapy delivery.
  • Requires an AW workstation with additional applications (e.g., Volume Viewer, Vision 2, VesselIQ Xpress, AutoBone Xpress), which are sold separately.
  • The AI Segmentation option is validated for the adult population only.
  • Injection points should be confirmed independently of FlightPlan for Embolization prior to therapy delivery.
  • May not be available for sale in all countries or regions.

Based on reviews from: fda.gov, gehealthcare.com, car-asm.ca, firstwordhealthtech.com, mic-tw.com, nih.gov, financialcontent.com, stocktitan.net

Last updated: 2026-10-30

Ratings & Reviews

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Press & Coverage

gehealthcare.com
GE HealthCare introduces Allia upgrade pathways designed to modernize existing interventional suites
GE HealthCare announced Allia platform upgrade pathways to modernize existing interventional suites, including access to Embo ASSIST AI, which features FlightPlan for Embolization with an AI Segmentation option. These upgrades aim to enhance efficiency and procedural decision-making while extending the lifetime of interventional rooms.
2026-06
fda.gov
FlightPlan for Embolization with AI Segmentation option - 510(k) Premarket Notification Submission
The FDA cleared GE HealthCare's FlightPlan for Embolization with an AI Segmentation option in March 2023. This software-only application aids in visualizing vasculature for planning endovascular embolization procedures using 3D X-ray angiography images.
2023-03
interventionalnews.com
How AI is streamlining embolization procedures in the outpatient setting
An article discusses how GE HealthCare's Embo ASSIST AI software, which includes FlightPlan for Embolization, is being used to streamline embolization procedures in an outpatient interventional radiology clinic. The technology aims to improve physician performance, reduce procedural time, and enhance cost-effectiveness.
2024-03
fda.gov
FlightPlan for Embolization - 510(k) Premarket Notification
The FDA cleared FlightPlan for Embolization in January 2020, stating it is a post-processing software package that assists in the analysis of 3D X-ray angiography images for planning embolization procedures. The FDA concluded that the device is as safe and effective as its predicate device.
2020-01
fda.gov
FlightPlan for Liver - 510(k) Premarket Notification
The FDA cleared FlightPlan for Liver in October 2021, a post-processing software package that helps analyze 3D X-ray angiography images of the liver to visualize vasculature and identify arteries for embolization planning. This device employs similar technology to FlightPlan for Embolization.
2021-10
nih.gov
FlightPlan for Embolization: A Report of Two Cases
A peer-reviewed article from 2024 highlights the use of "Flight Plan for Embolization" (FPFE) technique to identify feeding arteries in carotid body tumors, aiming to improve surgical outcomes by minimizing bleeding and nerve damage. The software simulates blood flow distribution to aid in planning.
2024-01

Videos

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Frequently Asked Questions

FlightPlan for Embolization, as part of the Embo ASSIST AI solution, includes an AI Segmentation option. This uses deep-learning based algorithms for automatic segmentation of vasculature, which aids in planning embolization procedures.
FlightPlan for Embolization is a FDA-cleared, post-processing software package. It complies with NEMA PS 3.1 - 3.20 DICOM standards and is designed and manufactured under the Quality System Regulations of 21CFR 820 and ISO 13485.
FlightPlan for Embolization is intended for use during the planning phase of embolization procedures and is not intended for use during therapy delivery. The AI Segmentation option is validated for the adult population only.
GE HealthCare offers a suite of 'ASSIST' solutions for various interventional procedures, including EVAR ASSIST 2 for EVAR procedures and Valve ASSIST 2 for valve positioning. These tools provide planning, guidance, and assessment capabilities for different clinical needs.
FlightPlan for Embolization with the AI Segmentation option requires an AW workstation with Volume Viewer, Volume Viewer Innova, Vision 2, VesselIQ Xpress, and Autobone Xpress. These applications are sold separately.
FlightPlan for Embolization is a post-processing software that analyzes 3D X-ray angiography images to help physicians visualize vasculature. This aids in the planning phase of embolization procedures, including the selection of embolization injection points.
No, FlightPlan for Embolization is intended as an adjunct means to help visualize vasculature during the planning phase of embolization procedures. Proceduralists must refer to standard of care imaging and prioritize clinical experience and judgment.

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Suggest an Edit → | Report an issue | Last Verified: 2026-04-18 | First Added: 2026-04-18
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