FLASH EVD System (10-0002)
Overview
The FLASH EVD System (10-0002) by 7D Surgical ULC (an Orthofix company) is a stereotactic image-guided surgical navigation system designed specifically for cranial procedures. It assists neurosurgeons in the spatial positioning, orientation, and placement of external ventricular drainage (EVD) catheters.
The system is engineered for use by neurosurgeons and neurocritical care specialists in both operating rooms and bedside care settings, such as intensive care units, where urgent ventriculostomies are performed to relieve elevated intracranial pressure. Unlike traditional navigation platforms, FLASH EVD is a pinless solution that does not require a skull clamp or rigid patient fixation, allowing it to fit seamlessly into demanding bedside clinical workflows without altering established procedural setups.
Key capabilities of the system include:
- LiveTrack Machine Vision: Utilizes proprietary camera-based hardware and software to capture over one million virtual fiducial points using visible light, enabling contactless patient registration in seconds.
- Electromagnetic-Free Tracking: Tracks disposable surgical instruments via integrated LiveTrack tile markers, eliminating the need for electromagnetic emitters or optical marker spheres.
- Bedside Portability: Features a highly maneuverable cart and a touchscreen interface with on-screen workflow assistance, designed to optimize space in crowded clinical environments.
- Zero-Assembly Procedural Kits: Employs single-use, disposable kits compatible with existing cranial access kits and catheters.
Reviewed by Pouyan Golshani, MD — Interventional Radiologist
Key Features
- Machine-Vision Technology (LiveTracku2122 System)
- Radiation-free navigation
- Fast patient registration (less than 30 seconds)
- No skull clamp or rigid patient fixation required
- Bedside procedure capability
- Portable and easily maneuverable cart
- Intuitive touchscreen interface with on-screen workflow assistance
- Single-use, disposable procedural kit
- Vendor-agnostic platform (compatible with most catheter brands)
- Lightweight LiveTrack surgical tools without marker spheres
Use Cases
- Placement of external ventricular drains (EVDs)
- Cranial surgery requiring image guidance
- Management of acute hydrocephalus
- Treatment of traumatic brain injuries
- Monitoring and relieving increased intracranial pressure
- Surgical planning and navigation for brain tumors (in conjunction with EVD placement)
What Physicians Need to Know
The FLASH EVD System offers a significant advantage by providing operating room accuracy for cranial catheter placement directly at the patient's bedside. Its machine-vision technology allows for quick, radiation-free registration and instrument tracking, minimizing radiation exposure for both staff and patients. This system streamlines the EVD placement workflow, potentially reducing complications associated with freehand techniques and improving overall efficiency in critical care settings.
The FLASH EVD System is designed for seamless integration into existing bedside procedures, compatible with various beds, catheters, and cranial access kits. It is a vendor-agnostic platform for catheter brands and utilizes pre-operative imaging (CT and MRI) for surgical planning and real-time navigation. The broader 7D FLASH Navigation System, which includes the EVD platform, can also leverage AI-powered software to generate synthetic CT from MRI scans for planning.
Details
| Category | Neurology AI, Surgical AI |
| Pricing |
Contact for pricing
|
| Deployment | On-premise (physical cart/system in hospital/bedside) |
| Compliance | |
| BAA Available | Unknown AI-estimated |
| HIPAA Compliant | Yes AI-estimated |
| FDA Status |
1 AI-estimated The FLASH EVD System (10-0002) received FDA 510(k) clearance (K242480) on December 27, 2024, as a Class II Stereotaxic Instrument (Product Code HAW) for cranial surgery, specifically for spatial positioning and orientation of neurosurgical instruments without rigid patient fixation. |
| Integrations | |
| EHR | Not specified |
| Specialties | Critical Care, Neurology, Neurosurgery |
What the Web Says
The Orthofix FLASH EVD System (10-0002) is a navigation platform designed to assist physicians in placing cranial catheters at the bedside with operating room accuracy. It utilizes proprietary machine-vision technology (LiveTracku2122 System developed with 7D Surgicalu00ae Technology) for instrument tracking and patient registration, eliminating the need for skull clamps, rigid patient fixation, or electromagnetic emitters. The system aims to streamline workflow, reduce radiation exposure, and improve accuracy in external ventricular drain (EVD) placements, particularly in challenging anatomical cases and for less experienced surgeons.
Overall: PositiveStrengths
- Operating room accuracy at the bedside.
- No skull clamp or rigid patient fixation required.
- Patient registration in seconds.
- Machine-vision instrument tracking without electromagnetic emitters.
- Intuitive touchscreen interface with on-screen workflow assistance.
- Portable and easily maneuverable cart.
Limitations
- No specific cons were found in the provided search results from physicians, healthcare IT, tech reviewers, Reddit, G2, or Capterra.
- General downsides of EVD guidance devices can include cost and potential procedural changes that may increase overall placement time.
Based on reviews from: Orthofix, HaRi, accessdata.fda.gov, Dallas Innovates, Medical Device Network, OR Today, PubMed, Reddit
Last updated: 2026-07-17
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