ENT EM

by Brainlab AG  · Based in Germany → — Advanced Electromagnetic Navigation for ENT Sinus Surgery
Otolaryngology (ENT)

Contact for pricing
Regulatory Status Disclosed

Overview

Brainlab Kick® EM is a sophisticated electromagnetic (EM) surgical navigation system designed for Ear, Nose, and Throat (ENT) procedures, particularly sinus surgery. It provides surgeons with advanced 3D displays, user-friendly touch-based and touchless patient registration options, and real-time virtual anatomy updates. The system continuously tracks surgical instruments during delicate procedures like functional endoscopic sinus surgery (FESS), enhancing precision and confidence. Its minimalistic design makes it portable and easy to set up, consisting of a field generator, connection panel, and Kick monitor cart. The software is installed on mobile Image Guided Surgery (IGS) platforms like the Kick 2 Navigation Station or Curve Navigation 17700. Brainlab generally integrates artificial intelligence into its platforms, and testing for the ENT EM device has shown equivalent performance with and without AI/ML components, indicating its presence within the system to support advanced functionalities and potentially automate workflows.

Reviewed by Pouyan Golshani, MD — Interventional Radiologist

Key Features

  • Electromagnetic (EM) tracking technology
  • Advanced 3D displays for anatomical visualization
  • User-friendly touch-based and touchless patient registration options
  • Real-time virtual anatomy updates
  • Continuous tracking of surgical instruments
  • Automated workflows for efficiency
  • Minimalistic, portable, and easy-to-set-up design
  • Large tracking volume for positional freedom
  • 21.5u201d full HD drapable touch display
  • Seamless instrument navigation and integration
  • AI/ML components for enhanced performance and future capabilities

Use Cases

  • Functional Endoscopic Sinus Surgery (FESS)
  • Intranasal surgeries
  • Maxillary antrostomies
  • Ethmoidectomy surgery
  • Sphenoidotomies/sphenoid explorations
  • Frontal and lateral skull base procedures

What Physicians Need to Know

Surgical Planning Capabilities
Brainlab ENT Navigation, which includes Kick EM, offers advanced 3D displays and visualization options. It utilizes pre-operative CT and/or MR images for detailed planning.
Intraoperative Guidance
Kick EM is specifically designed for electromagnetic navigated ENT sinus surgery, providing continuous, real-time tracking of surgical instruments relative to the patient's anatomy. It offers seamless instrument navigation, integrating pointers and suctions, and features real-time virtual anatomy updates on advanced 3D displays. Electromagnetic tracking ensures positional freedom without line-of-sight issues.
3D Reconstruction Quality
The system leverages pre-operative CT and/or MR images to create 3D representations for surgical guidance. Brainlab's broader ENT navigation solutions offer advanced 3D displays and can integrate with Mixed Reality Viewers for realistic, patient-specific 3D reconstructions.
Robotic Surgery Integration
While Brainlab offers a comprehensive Robotic Suite (Loop-X, Curve, Cirq) designed for surgical precision and workflow integration across various disciplines, ENT EM is primarily a navigation system. Brainlab's robotic technology is developed to support clinical workflows and can be part of a broader integrated O.R. ecosystem.
Surgical Navigation Accuracy
Surgical navigation continuously tracks instruments with respect to the patient's anatomy, crucial for complex ENT procedures near sensitive structures. Brainlab ENT Navigation offers user-friendly touch-based and touchless patient registration options. Studies on Brainlab navigation systems in endoscopy have reported median precision in the range of 1.3 mm to 2.3 mm in surgical conditions, with electromagnetic navigation-assisted endoscopy showing accuracy between 2.5 and 9 mm. Proper registration technique is critical for maintaining accuracy.
Pre-Operative Assessment
ENT EM utilizes pre-operative scanned images (MR and/or CT) of the patient. Brainlab's ENT navigation systems provide advanced 3D visualization options to support comprehensive pre-operative assessment and planning for complex procedures.
Operating Room Workflow Integration
Kick EM features a minimalistic, portable design with a large tracking volume and a 21.5u201d full HD drapable touch display for easy interaction. It supports seamless instrument navigation and offers instrument tip calibration in seconds. The Buzzu00ae Digital O.R. extension provides remote control and integrated O.R. functionalities, enhancing automated workflows and data management.
Physician Tip

To maximize the benefits of Brainlab ENT EM, physicians should prioritize meticulous patient registration, as accuracy is highly dependent on this step. Leverage the system's advanced 3D visualization and real-time electromagnetic instrument tracking, especially in anatomically complex regions during sinus surgery, to enhance precision and safety. The remote capabilities of the EM pointer and streamlined workflows should be utilized to maintain focus on the surgical field and improve procedural efficiency.

Brainlab ENT EM (Kick EM) is designed for seamless integration of both Brainlab and third-party instruments via Instrument Adapter EM. It offers specific integration with multidebriders, such as the Olympus Diegou00ae Elite Multidebrideru00ae. The system can be extended with Buzzu00ae Digital O.R. for remote control and enhanced O.R. functionalities, fitting into Brainlab's broader ecosystem of digital surgery platforms that support various intraoperative imaging and robotic solutions.

Details

Category Surgical AI
Pricing Contact for pricing
DeploymentSoftware installed on mobile Image Guided Surgery (IGS) platforms (e.g., Kick 2 Navigation Station or Curve Navigation 17700), comprising a mobile monitor cart, connection panel, and field generator.
Compliance
BAA AvailableUnknown AI-estimated
HIPAA CompliantUnknown AI-estimated
FDA Status 1 AI-estimated

The device, 'ENT EM', received FDA 510(k) Premarket Notification clearance (K223734) on April 27, 2023, classified as a Class II Stereotaxic Instrument (Product Code PGW) for Ear, Nose, and Throat procedures.

Integrations
EHR Not specified
Specialties Otolaryngology (ENT)

What the Web Says

Brainlab ENT EM is an image-guided planning and navigation system designed for ENT procedures, utilizing electromagnetic tracking technology. It aims to enhance safety and efficiency in surgery by merging preoperative image data with real-time instrument tracking. The system has undergone usability evaluations in simulated clinical environments and performance testing, demonstrating accuracy comparable to predicate and reference devices.

Overall: Positive

Strengths

  • Provides real-time instrument tracking for enhanced spatial orientation in ENT surgery.
  • Utilizes AI/ML for landmark detection, showing equivalent performance to conventional methods.
  • Offers an intuitive user interface with touch gesture, mouse, and keyboard support.
  • Compatible with various imaging modalities (CT, MR, PET/SPECT, X-ray) and PACS systems for data import and export.
  • Designed for precise, efficient, and safe navigation in ENT surgery.
  • Features autoclavable instruments and high-precision glass reflectors for improved tracking.

Limitations

  • Electromagnetic tracking technology can be sensitive to distortions from medical diagnostic devices (CT/MRI) and ferromagnetic objects.
  • System accuracy may be affected by the operating room setup, including monitors and the base station.
  • Potential prolongation of surgery duration depending on OR setup, patient positioning, and calculation complexity.
  • Requires careful reading of user guides due to the complex nature of the medical software and devices.
  • Older versions of the software (e.g., ENT EM 1.0) had reported issues with potentially incorrectly displayed objects when deselecting fused reference datasets.
  • Optimal performance requires specific PACS configurations and network speeds.

Based on reviews from: FDA.report, Amazon S3, PMC, BidMed, FDA, Brainlab, ErgoSurg, Elektronische Hochschulschriften der LMU Mu00fcnchen, Pocket Dentistry

Last updated: 2026-07-18

Ratings & Reviews

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Press & Coverage

GlobalData
BrainLAB receives 510(k) clearance for ENT EM Instrument
Brainlab received 510(k) clearance for its ENT EM Instrument on May 5, 2023.
2023-05
FDA
510(k) Premarket Notification - ENT EM
The FDA granted 510(k) clearance for Brainlab AG's ENT EM device on April 27, 2023.
2023-04
FDA.report
Re: K223734 Trade/Device - FDA.report
The ENT EM 1.2 software, which includes an AI/ML feature for landmark detection in registration, received FDA clearance on April 27, 2023, demonstrating equivalent performance to the reference device without AI/ML.
2023-04
Annals of Biomedical Engineering (PMC)
In Vitro Assessment and Comparison of a Novel Electromagnetic Tracking System for Stereotactic DBS Surgery
This peer-reviewed article, published in April 2025, discusses electromagnetic tracking systems for neurosurgery, mentioning Brainlab's Kick EM system as a state-of-the-art option integrated into surgical platforms.
2025-04
Brainlab
CE marking - Brainlab
Brainlab lists ENT EM 1.2 with CE 0123 marking, indicating its conformity with European health, safety, and environmental protection standards.
unknown
Elektronische Hochschulschriften der LMU Mu00fcnchen
Arbeitsbelastung und Disstress bei der Anwendung eines elektromagnetischen Navigationssystems in der funktionellen endoskopischen Nasennebenhu00f6hlenchirurgie.
This academic work from February 2022 details the use of Brainlab's ENT EM version 1.0 software for electromagnetic navigation in functional endoscopic sinus surgery, including the process of importing patient data and registration.
2022-02
FDA
MAUDE Adverse Event Report: BRAINLAB AG NAVIGATION SW ...
An FDA MAUDE adverse event report from April 2026 mentions Brainlab AG's Navigation SW Cranial EM (Version 1.1) and Navigation SW ENT EM 1.1.
2026-04
Anvisa
INSTRUu00c7u00d5ES DE USO - Anvisa
This document from Anvisa, dated January 2025, includes ENT EM 1.2 in a software compatibility guide for Brainlab systems.
2025-01

Videos

Product demos, reviews, and walkthroughs for ENT EM.

View all on YouTube

Frequently Asked Questions

AI tools can integrate by providing real-time diagnostic support for imaging or symptom analysis, automating documentation, or triaging patient cases. This allows physicians to focus more on complex decision-making and patient interaction, ultimately streamlining workflow and potentially enhancing diagnostic precision.
Reputable AI solutions employ robust encryption, de-identification techniques, and secure cloud infrastructure to protect patient data. They also adhere to strict regulatory frameworks like HIPAA and GDPR, often undergoing regular audits to maintain compliance and data security standards.
Many clinical AI tools, especially those impacting diagnosis or treatment decisions, undergo FDA review for clearance or approval, signifying they meet specific safety and efficacy standards. This regulatory oversight provides a level of assurance regarding their reliability, intended use, and clinical validity.
AI models can exhibit biases if trained on unrepresentative datasets, potentially leading to disparities in care or misdiagnoses for certain patient populations. Limitations also include difficulty with rare conditions or nuanced clinical presentations, necessitating continuous model validation, diverse training data, and crucial human oversight.
AI often offers faster processing of large datasets and can identify subtle patterns missed by the human eye, potentially increasing diagnostic speed and accuracy. While traditional methods provide foundational clinical context and human expertise, AI augments these by optimizing resource utilization and reducing cognitive load, rather than fully replacing them.
Pricing models vary, often including subscription fees based on usage, features, or per-physician licenses, with some offering tiered access. ROI can be realized through improved diagnostic efficiency, reduced administrative burden, better patient outcomes, and potentially increased patient throughput, leading to enhanced practice profitability and patient satisfaction.

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