Brainlab Elements Image Fusion Angio (1.0)

by Brainlab  · Based in Germany → — Innovating Medtech for Better Patient Outcomes
Neurosurgery Oncology Radiology

Regulatory Status Disclosed

Overview

Brainlab Elements Image Fusion Angio (1.0) is a specialized software application designed for the co-registration of cerebrovascular medical image data. Developed by Brainlab AG, the software processes and aligns complex vascular datasets to support clinicians during pre-planning phases.

The application is primarily utilized by neurosurgons, neuroradiologists, and radiation oncologists in hospital and specialized surgical or radiotherapy centers. It is indicated for the planning of cranial surgical treatments and the preplanning of cranial radiotherapy treatments.

In a clinical workflow, the tool integrates into the pre-planning stage by allowing clinicians to combine planar digital subtraction angiography (DSA) images with volumetric imaging datasets, such as CT or MRI. This co-registration helps align anatomical and vascular structures, streamlining the target definition process for cranial interventions.

Notable Capabilities:

  • Vascular Co-Registration: Specifically designed to align 2D and 3D cerebrovascular datasets, including angiography, to assist in mapping complex vascular structures.
  • Workflow Integration: Works alongside other modules in the Brainlab Elements suite, such as Contouring and Fibertracking, to build a comprehensive anatomical model.
  • Flexible Deployment: Supports DICOM data transfer and can be accessed across multiple platforms, including dedicated planning workstations and mobile devices.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Co-registration of cerebrovascular image data
  • Image fusion (aligning different imaging datasets)
  • Angiographic image registration
  • Supports planning of cranial surgical treatments
  • Supports preplanning of cranial radiotherapy treatments
  • Visualization of anatomical structures
  • Integration with other Brainlab Elements modules (e.g., SmartBrush Angio, Mixed Reality Viewer)
  • Utilizes 2D DSA and 3D rotational angiography-based Cone-Beam CT Angiogram (CBCTA)
  • Frameless co-registration
  • Not intended for diagnostic purposes

Use Cases

  • Planning cranial surgical treatments
  • Preplanning cranial radiotherapy treatments
  • Stereotactic radiosurgery (SRS) for intracranial arteriovenous malformations (AVMs) and dural arteriovenous fistulas (DAVFs)
  • Enhanced surgical planning review with patient-specific 3D data
  • Combining insights from planar digital subtraction angiogram (DSA) with volumetric imaging data

What Physicians Need to Know

Brain MRI/CT Analysis
Brainlab Elements Image Fusion Angio (1.0) is designed for the co-registration of cerebrovascular image data, allowing the fusion of 2D Digital Subtraction Angiography (DSA) sequences with MRA, CTA, and 3D DSA sequences. This enables the combination of flow and location information from different imaging modalities. The software is part of the Brainlab Elements suite, which processes medical image data to assist in image-guided surgery and radiation treatment planning. It facilitates the alignment and manipulation of medical images through features like contouring, image fusion, and visualization of white matter tracts or blood oxygen level data. The system converts traditional 2D medical scans (MRIs and CTs) into interactive 3D anatomical maps, providing GPS-level precision for navigation. It also includes AI features for identifying previously diagnosed lesions or tumors in T1-Weighted Contrast-Enhanced Magnetic Resonance (T1+C MR) volumetric images, utilizing a Convolutional Neural Network (CNN) developed with a supervised learning approach.
Physician Tip

Brainlab Elements Image Fusion Angio (1.0) is particularly useful for neurosurgeons and radiation oncologists in planning complex cerebrovascular interventions. The ability to fuse 2D DSA with 3D volumetric data (MRA, CTA, 3D DSA) provides a comprehensive view of vascular anatomy and flow dynamics, which is crucial for precise target definition and critical structure avoidance. The AI-powered tumor segmentation can assist in efficient contouring, but always verify the AI-generated contours with careful manual review. Leveraging the 3D anatomical maps derived from MRI and CT scans can enhance surgical navigation and improve confidence in the operating room. The software's multi-platform flexibility allows for planning and review on various devices, including mobile, which can be beneficial for busy clinicians.

Brainlab Elements Image Fusion Angio (1.0) is a module within the broader Brainlab Elements suite, which is designed for seamless integration across various clinical subspecialties like neurosurgery and radiation oncology. It integrates with platforms such as Curve™ Image Guided Surgery and Buzz® Digital O.R. to enhance workflow efficiency. The software is compatible with DICOM data, allowing transfer to and from PACS and other storage media devices. It supports collaboration across departments and locations, with compatibility for mobile devices and workstations.

Details

Category Neurology AI, Oncology AI, Surgical AI
Pricing Unknown
DeploymentOn-premise (Windows platforms with specific hardware requirements), with capabilities for multi-device access including iPad and iPhone, and cloud-based data sharing.
Mobile App1
Compliance
BAA AvailableUnknown
HIPAA Compliant Yes AI-estimated
FDA Status Yes AI-estimated
Integrations
EHR Not specified
Specialties Neurosurgery, Oncology, Radiology

What the Web Says

Brainlab Elements Image Fusion Angio (1.0) is a software application designed for co-registration of cerebrovascular image data, allowing the fusion of 2D Digital Subtraction Angiography (DSA) sequences with MRA, CTA, and 3D DSA sequences. [8] This technology aims to enhance treatment planning, particularly for conditions like arteriovenous malformations (AVMs) and dural arteriovenous fistulas (DAVFs), by combining flow and location information. [1, 8] It is part of the broader Brainlab Elements suite, which provides various modules for processing medical image data to support image-guided surgery and radiation treatment planning. [5, 8]

Overall: Positive

Strengths

  • Enhances treatment workflow and circumstances for both frame-based and frameless stereotactic radiosurgery (SRS). [1]
  • Allows for the convenient and clinically useful co-registration of biplane 2D-DSA whole frames and CBCTA. [1]
  • Dramatically reduces treatment time and burdens on both patients and medical professionals by omitting the need for invasive angiography on the day of SRS. [1]
  • Provides adequate image datasets for SRS planning, including unenhanced CT for dose calculation, MRI for accurate target localization, and 2D/3D fused angiogram for target delineation. [1]
  • Facilitates the fusion of multiple imaging modalities, making radiosurgical and surgical planning for AVMs more accurate. [4]
  • Eliminates the need for additional planning digital subtraction angiography (DSA) for nidus identification by fusing pre-existing diagnostic DSA with volumetric MRI and CT images. [4]

Limitations

  • Requires routine acquisition of both subtracted and unsubtracted CBCTA for successful image fusion and broad applications. [1]
  • Dependency on proper hardware and user expertise for effective operation. [5]
  • Requires a computing environment that meets specific hardware criteria. [5]
  • Requires trained personnel to correctly interpret and utilize the processed images. [5]
  • AI features depend heavily on the input image quality and parameters set by the user. [5]
  • The use of image fusion is associated with the risk of error introduced by inaccuracies of the fusion process. [18]

Based on reviews from: nih.gov, brainlab.com, medicalnewsobserver.com, fda.gov

Last updated: 2026-10-29

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Press & Coverage

fda.gov
Brainlab Elements Image Fusion Angio (1.0) - FDA 510(k) K223106
Brainlab Elements Image Fusion Angio is a software application for co-registration of cerebrovascular image data, allowing fusion of 2D DSA sequences with MRA, CTA, and 3D DSA sequences to combine flow and location information. It also includes AI features for identifying previously diagnosed lesions or tumors in T1-Weighted Contrast-Enhanced Magnetic Resonance (T1+C MR) volumetric images.
2023-07
fda.gov
Brainlab Elements (7.0); Brainlab Elements Image Fusion (5.0); Brainlab Elements Image Fusion Angio (1.0); Brainlab Elements Contouring (5.0); Brainlab Elements Fibertracking (3.0); Brainlab Elements BOLD MRI Mapping (1.0) - FDA 510(k) K243633
This FDA 510(k) premarket notification lists Brainlab Elements Image Fusion Angio (1.0) as part of a suite of Brainlab Elements software applications.
2025-06
fda.gov
Brainlab Elements Image Fusion Angio (1.0) - FDA 510(k) K212420
Brainlab Elements Image Fusion Angio (1.0) is a software application intended for the co-registration of cerebrovascular image data, enabling the alignment of anatomical structures between different datasets using rigid and deformable registration methods.
2021-12
brainlab.com
Brainlab Elements Image Fusion Angio 1.0 CE Mark
Brainlab Elements Image Fusion Angio 1.0 has received CE 0123 mark from TÜV SÜD Product Service GmbH.
unknown
innolitics.com
Automated Radiological Image Processing Software (QIH)
Brainlab Elements Image Fusion Angio (1.0) is listed among recent cleared devices under the product code QIH for Automated Radiological Image Processing Software, which includes AI features for identifying previously diagnosed lesions or tumors.
2025-06
fda.gov
Brainlab Elements Image Fusion Angio (1.0) - MeVis AVM Contour predicate device
Brainlab Elements Image Fusion Angio (1.0) is identified as a predicate device for MeVis AVM Contour, a specialized medical imaging software tool for DICOM CT, biplanar X-Ray and DSA images.
2026-06

Videos

Product demos, reviews, and walkthroughs for Brainlab Elements Image Fusion Angio (1.0).

View all on YouTube

Frequently Asked Questions

Brainlab Elements Image Fusion Angio (1.0) incorporates AI features primarily for the identification of previously diagnosed lesions or tumors in T1-Weighted Contrast-Enhanced Magnetic Resonance (T1+C MR) volumetric images. This AI/ML algorithm, a Convolutional Neural Network (CNN) developed using a Supervised Learning approach, complements or is preferred over older tumor segmentation algorithms when suitable T1+C MR volumes are available.
Brainlab Elements Image Fusion Angio (1.0) is designed for the co-registration of cerebrovascular image data, allowing for the fusion of 2D Digital Subtraction Angiography (DSA) sequences with MRA, CTA, and 3D DSA sequences. This combines flow and location information, which is crucial for treatment planning, including target definition for stereotactic radiosurgery (SRS) for conditions like intracranial arteriovenous malformations (AVMs) and dural arteriovenous fistulas (DAVFs).
Brainlab Elements Image Fusion Angio (1.0) is a software application classified as an automated radiological image processing software. It has received 510(k) clearance from the FDA, indicating that it is substantially equivalent to predicate devices.
The Brainlab Elements suite, including Image Fusion Angio, is dependent on proper hardware and user expertise. Effective operation requires a computing environment that meets specific hardware criteria and trained personnel to correctly interpret and utilize the processed images. Additionally, the software's AI features, while advanced, depend heavily on the input image quality and parameters set by the user.
While Brainlab Elements Image Fusion Angio (1.0) is noted as a commercially available software for frameless 6-degree-of-freedom co-registration of 2D-DSA whole frames into stereotactic 3D vasculature-visible images, other companies like Medtronic, Stryker, and Zimmer Biomet also offer surgical navigation systems that may include image fusion capabilities.
Brainlab Elements Image Fusion Angio can be combined with other Brainlab products like Elements SmartBrush Angio and the Mixed Reality Viewer to review patient vasculature, outline craniotomy sizes, and anticipate vascular clip positioning. It integrates into surgical planning workflows, providing a fully immersive environment for understanding, visualizing, and preparing for neurosurgical cases.
AI-based 3D angiography, such as that used in Brainlab Elements Image Fusion Angio, can potentially offer a considerable reduction in patient radiation dose compared to traditional 3D-DSA, as it may not require a mask run. Studies have shown that AI tools can identify a higher number of intracranial aneurysms than radiologists alone, particularly smaller ones, suggesting complementary detection abilities.

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Suggest an Edit → | Report an issue | Last Verified: 2026-04-17 | First Added: 2026-04-17
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