ENT EM
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
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 |
| Deployment | Software 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 Available | Unknown AI-estimated |
| HIPAA Compliant | Unknown 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: PositiveStrengths
- 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
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Kicku00ae EM for ENTu2014Electromagnetic Navigation for Sinus Surgery
