Alignment System Cranial

by Brainlab AG  · Based in Germany → — Extending human capabilities with a robotic platform for neurosurgery.
Neurosurgery

Contact vendor for pricing
Regulatory Status Disclosed

Overview

The Alignment System Cranial, featuring the Cirq Robotic Alignment Module, is a sophisticated robotic surgical system developed by Brainlab AG. It is designed to enhance precision and efficiency in cranial stereotactic procedures. The system automatically aligns to patient-specific trajectories, guiding tracked surgical instruments with high accuracy. It seamlessly integrates into Brainlab’s comprehensive planning and cranial navigation solutions, optimizing workflows for neurosurgeons.

Key applications include biopsies of intracranial lesions and the precise placement of stereoelectroencephalography (sEEG) electrodes for functional neurosurgery, such as in epilepsy treatment. The modular design allows for flexible integration into various operating room setups, providing an automated surgical assistant that can reliably align to pre-planned trajectories while allowing for manual adjustments by surgeons. The system supports various patient registration methods, including bone screw fiducials and surface matching, and offers real-time tracking and guidance during procedures.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Robotic alignment to pre-planned trajectories
  • Seamless integration with Brainlab planning and navigation software
  • Real-time tracking and guidance of surgical instruments
  • Modular design (Cirq Robotic Alignment Module)
  • Supports various patient registration methods (e.g., bone screw fiducials, surface matching)
  • Automated assistance for precise instrument positioning
  • Vendor-neutral compatibility with multiple implant sets and workflows
  • Compact, table-mounted, and lightweight system
  • Digital guidance and robotic precision for cranial tumor workflows
  • Streamlined workflow for efficient instrumentation

Use Cases

  • Cranial biopsies of intracranial lesions
  • Placement of stereoelectroencephalography (sEEG) electrodes
  • Functional neurosurgery (e.g., sEEG electrode placement for epilepsy)
  • Planning and execution of cranial stereotactic procedures
  • Support for minimally invasive tumor procedures
  • Robotic assistance in neurosurgical workflows

What Physicians Need to Know

Brain MRI/CT Analysis (Surgical Planning & Guidance)
The system offers automatic segmentation of anatomical structures including skin, bone, cortical vessels, cerebrum, and basal ganglia. It provides a 3D preview of lesions and critical structures, aiding in optimal craniotomy and approach planning. It also features image fusion with distortion correction for MRI, enhancing the accuracy of tractography.
Intraoperative Imaging Integration
Seamlessly integrates intraoperative MRI (iMRI), intraoperative CT (iCT), and ultrasound with automatic image registration. This allows for real-time updates to navigation, compensating for brain shift and providing immediate quality control and navigation on up-to-date images during procedures.
High-Precision Alignment & Navigation
Facilitates high-precision robotic and manual alignment to pre-planned trajectories for cranial stereotactic procedures such as biopsies, sEEG electrode placement, and LITT. It offers continuous position feedback and precise step-by-step workflow guidance, enhancing accuracy and efficiency.
Surgical Workflow Efficiency
Features time-saving patient registration techniques like Z-touch and Softouch, which utilize surface matching to register CT and MR images without the need for headsets or markers, potentially reducing costs and setup time. Automated data selection and layout composition further streamline the surgical workflow.
Physician Tip

Leverage the system's advanced 3D visualization and automatic segmentation for meticulous preoperative planning, especially for complex trajectories and proximity to eloquent areas. Utilize intraoperative imaging integration to dynamically update navigation and account for brain shift, ensuring continuous accuracy during resection or electrode placement. Employ the robotic alignment capabilities for consistent precision in stereotactic procedures, which can enhance procedural efficiency and patient comfort. Integrate with existing imaging modalities to maximize the benefits of real-time guidance and minimize the need for additional registration scans. For biopsies, the frameless approach with VarioGuide or Cirq can offer precision comparable to frame-based methods while improving patient comfort.

The Alignment System Cranial is designed for seamless integration within the Brainlab ecosystem, including planning software (e.g., Elements Trajectory Planning, Elements Segmentation) and navigation platforms (e.g., Curve Navigation, Kick Navigation). It supports integration with various intraoperative imaging devices such as iMRI, iCT, rotational angiography, cone-beam CT, and real-time ultrasound. Furthermore, it integrates with major surgical microscope vendors, providing augmented reality overlays directly in the surgeon's field of view. It is also compatible with active positioning devices like the Cirq Arm System and passive devices like VarioGuide.

Details

Category Neurology AI, Surgical AI
Pricing Contact vendor for pricing
  • Not publicly available; pricing for similar robotic systems can range significantly based on configuration and market
DeploymentOn-premise (integrated with hospital OR infrastructure)
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

The Alignment System Cranial (K223864) received FDA 510(k) clearance on September 9, 2023. It is intended to support surgeons in planning and achieving trajectories with surgical instruments during cranial stereotactic procedures, specifically for biopsy of intracranial lesions and placement of stereoelectroencephalography (sEEG) electrodes.

Integrations
EHR Not specified
Specialties Neurosurgery

What the Web Says

The Brainlab Alignment System Cranial is a robotic surgical system designed to enhance precision and efficiency in cranial stereotactic procedures, such as biopsies and electrode placements. It integrates hardware and software, utilizing optical tracking technology and advanced imaging for real-time guidance and automated alignment. The system aims to streamline workflows and improve accuracy by providing surgeons with precise trajectory planning and continuous feedback.

Overall: Positive

Strengths

  • Enhances surgical precision and accuracy through software-driven guidance and real-time tracking.
  • Automates alignment to planned trajectories, reducing manual effort and increasing reproducibility.
  • Streamlines workflow for efficient instrumentation and organized setup, particularly for minimally invasive procedures.
  • Integrates seamlessly with Brainlab planning and navigation software, providing intuitive planning and real-time feedback.
  • Supports various imaging modalities (CT, MRI, X-Ray, ultrasound) for comprehensive anatomical reference.
  • Offers flexible configurations with different positioning devices, including active robotic arms and passive guides.

Limitations

  • No specific cons were identified in the provided search results from physicians, healthcare IT, tech reviewers, Reddit, G2, or Capterra.

Based on reviews from: Physician Ai Tools, accessdata.fda.gov, Brainlab, BEUDAMED, 510k Monitor, FDA.report, Journal of NeuroInterventional Surgery

Last updated: 2026-07-17

Ratings & Reviews

No reviews yet. Be the first to review this tool!

Rate Alignment System Cranial

Clinical Value
Ease of Use
Integration
Support & Docs
Value for Money

Press & Coverage

FDA
510(k) Premarket Notification K243698 - Alignment System Cranial, with Alignment Software Cranial with LITT
This regulatory announcement details the FDA 510(k) clearance for Brainlab's Alignment System Cranial with LITT, expanding its indications for use to include biopsy of intracranial lesions, placement of stereoelectroencephalography (SEEG) electrodes, and placement of anchor bolts for laser interstitial thermal therapy (LITT).
2025-01
Brainlab
Cranial Navigation: Advanced Neuronavigation - Brainlab
This page from Brainlab highlights their Cranial Navigation solutions, including the VarioGuide Alignment System and Cirq alignment software, emphasizing precision, efficiency, and patient comfort for navigated frameless biopsies and robotic alignment.
unknown
FDA
510(k) Premarket Notification - FDA (K223864)
This FDA 510(k) premarket notification details the clearance for Brainlab's Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial Biopsy, Cirq Alignment Software Cranial sEEG, and Varioguide Alignment Software Cranial.
2026-06
FDA
510(k) Premarket Notification - FDA (June 29 2026)
This FDA document lists various Brainlab Alignment System Cranial software components, including those for LITT, biopsy, and sEEG, under a 510(k) premarket notification.
2026-06
accessdata.fda.gov
K223864 - Trade/Device Name: Alignment System Cranial, Alignment Software Cranial, Cirq Alignment Software Cranial Biopsy, Cirq Alignment Software Cranial sEEG, Varioguide Alignment Software Cranial
This FDA document outlines the indications for use and device description for Brainlab's Alignment System Cranial, an image-guided surgery system utilizing optical tracking technology for cranial stereotactic procedures.
2023-09
FDA.report
BRAINLAB, INC. FDA Filings - FDA.report
This page lists various FDA filings by Brainlab, Inc., including the Alignment System Cranial and its associated software for biopsy and sEEG, with a filing date in September 2023.
2023-09
510k Monitor
Brainlab AG u2014 FDA 510(k) clearances & recalls u00b7 510k Monitor (K243698)
This entry on 510k Monitor confirms the FDA 510(k) clearance for Brainlab's Alignment System Cranial, including its software components for LITT, biopsy, and sEEG.
unknown

Videos

Product demos, reviews, and walkthroughs for Alignment System Cranial.

View all on YouTube

No FAQs available yet for this tool.

Related Tools

Cercare Medical Oncology Virtual Expert
Cercare Medical
Neurology AI
Cercare Medical's Oncology Virtual Expert is an AI-powered brain tumor segmentation module that provides fast, consistent, and semi-automated tumor analysis from standard MRI data, designed for on-premise deployment within existing clinical radiology workflows.
CoLumbo C-Spine
Smart Soft Healthcare AD
Clinical Decision Support & Reference
CoLumbo C-Spine is an AI-powered software that processes and analyzes cervical spine MRI exams, assisting clinicians in diagnosis and assessment.
MeRT System
Wave Neuroscience
Mental & Behavioral Health AI
MeRT (Magnetic e-Resonance Therapy) is an advanced, personalized form of TMS that uses your own brainwave data to guide treatment. It's a non-invasive, drug-free option designed to help the brain communicate more efficiently so symptoms of conditions like depression, anxiety, PTSD, TBI, autism, and more can improve.
Brainomix 360 Hyperdensity
Brainomix Limited
Neurology AI
Brainomix 360 Hyperdensity is an AI-powered neuroimaging software tool that detects and quantifies brain hyperdensities on CT scans, forming a crucial part of the Brainomix 360 Stroke platform for rapid and accurate stroke assessment.
SOMNUM
HoneyNaps
Clinical Decision Support & Reference
SOMNUM is an AI-enabled medical software tool by Honeynaps Co., Ltd. that provides comprehensive sleep analysis to aid in the diagnosis and management of sleep disorders.
DETECT-ME/CFS project
DETECT-ME/CFS project (ME/CFS Research Foundation)
Clinical Decision Support & Reference
The DETECT-ME/CFS project is developing an AI-supported clinical decision support system to improve the rapid and reliable diagnosis of Myalgic Encephalomyelitis/Chronic Fatigue Syndrome.

See all Neurology AI tools →

More from Brainlab AG

(Elements) Cranial SRS
Brainlab AG
Neurology AI
Elements Cranial SRS by Brainlab AG is an advanced software for stereotactic radiosurgery planning in cranial cases, offering automated, indication-specific treatment plans with 3D visualization and advanced optimization algorithms for precise and efficient dose delivery.
(Elements) Dose Review
Brainlab AG
Oncology AI
Brainlab Elements Dose Review is an AI-powered software for radiation therapy planning, offering detailed dose analysis, plan comparison, and segmentation for various anatomical regions as part of the broader Brainlab Elements suite.
(Elements) Retreatment Review
Brainlab AG
Neurology AI
Elements Retreatment Review is an AI-powered software by Brainlab AG that streamlines retreatment planning for multiple brain metastases by integrating prior treatment data, new scans, and AI-driven tumor segmentation for optimal decision-making.
(Elements) Spine SRS
Brainlab AG
Oncology AI
Brainlab Elements Spine SRS is an advanced, AI-powered software for highly automated and precise treatment planning of spinal metastases using stereotactic radiosurgery (SRS) and stereotactic body radiation therapy (SBRT). It offers features like spinal curvature correction, automatic target delineation, and optimized dose calculation for superior spinal cord sparing.

View company profile →

Suggest an Edit → | Last Verified: 2026-04-17 | First Added: 2026-04-17
AI Tool Finder
AI-powered search. Results may not be comprehensive.