LumiNE US
Subscription model
Regulatory Status Disclosed
Overview
LumiNE US by Augmedit B.V. is an AI-powered visualization software designed for surgical planning. It converts 2D MRI and CT scans into 3D models to provide insights into anatomy and pathology. The software is intended for neurosurgeons, neurosurgical residents, and other qualified medical professionals in hospital settings.
- What it does: LumiNE US creates 3D models from 2D MRI and CT images, utilizing AI-based algorithms for semi-automatic segmentation of structures like tumors, brain structures, skin, and ventricles. It enables augmented reality (AR) based visualization of patient data via wireless head-mounted displays, offering an immersive experience for surgical preparation.
- Who it is for: The tool is specifically tailored for neurosurgical staff for use in surgical planning.
- How it fits a clinical or practice workflow: LumiNE US integrates into the preoperative workflow by allowing surgeons and their teams to prepare for surgical procedures more efficiently through enhanced visualization of patient-specific 3D holograms. It is intended for the preparation phase of surgery and not for diagnostic use.
- Notable capabilities: Key features include 3D model creation, AR visualization, and AI-based segmentation capabilities. The software is compatible with hardware like the HoloLens 2.
Reviewed by Pouyan Golshani, MD — Interventional Radiologist
Key Features
- 3D Model Creation from 2D MRI and CT scans
- Augmented Reality (AR) based visualization via Head-Mounted Displays (HMDs)
- AI-based semi-automatic segmentation of tumors, brain structures, skin, and ventricles from MR scans
- Threshold-based segmentation for CT scans
- Cloud-based platform
- Compatible with Microsoft HoloLens 2
- Manipulation and surgical planning of 3D models including annotations and sharing functionalities
- Streamlined workflow for (neuro)surgeons and medical professionals
- DICOM visualization
- Hardware agnostic (HoloLens 2, web, mobile - coming soon)
Use Cases
- Pre-operative surgical planning
- Visualization of anatomy and pathology
- Training medical staff
- Patient education and engagement
What Physicians Need to Know
Brain MRI/CT Analysis
LumiNE US converts 2D MRI and CT scans into interactive 3D models to support surgical planning. It utilizes AI-based algorithms for semi-automatic segmentation of known tumors, brain structures, skin, and ventricles from contrast-enhanced MR scans, and a threshold-based segmentation for CT scans.
Augmented Reality Visualization
The platform enables augmented reality (AR)-based visualization of patient data via wireless Head-Mounted Displays (HMDs), providing an immersive experience for neurosurgeons during surgical preparation.
Surgical Planning Support
LumiNE US is designed to provide medical professionals with cutting-edge tools for visualizing anatomy and pathology, empowering neurosurgeons with enhanced insights during surgical preparation for previously diagnosed conditions. It is intended solely for the preparation phase of surgery, not for diagnostic purposes.
Workflow Streamlining
The software is specifically tailored for use by neurosurgeons, residents, and other qualified medical professionals within hospital settings to streamline the surgical preparation workflow.
FDA Clearance
LumiNE US software has received clearance from the U.S. Food and Drug Administration (FDA) for use in surgical planning.
Physician Tip
LumiNE US is a powerful tool for pre-operative planning, allowing neurosurgeons to visualize complex anatomy and pathology in 3D and augmented reality. It enhances spatial understanding and can improve communication with patients regarding their surgical procedure. Remember that LumiNE US is intended for surgical preparation of *previously diagnosed conditions* and should not be used for diagnostic purposes. Leverage its AI-driven segmentation for efficient 3D model creation and utilize the AR visualization for a more intuitive and immersive planning experience.
LumiNE US connects with DICOM images via a secure cloud platform, converting them into 3D volume models. It is hardware agnostic and compatible with Microsoft HoloLens 2 for AR visualization. Future compatibility with mobile devices is also indicated. This facilitates integration into existing hospital imaging workflows for efficient image transfer and processing.
Details
| Category | Neurology AI, Radiology & Imaging AI, Surgical AI |
| Pricing | Subscription model — Low priced subscription model |
| Deployment | Cloud-based |
| Compliance | |
| BAA Available | Unknown AI-estimated |
| HIPAA Compliant | Unknown AI-estimated |
| FDA Status |
1 AI-estimated LumiNE US received FDA clearance (K240094) on September 10, 2024, for use in surgical planning. It is intended for visualization of medical images to provide insights into anatomy and pathology in preparation for surgery and is not for diagnostic use. |
| Integrations | |
| EHR | Not specified |
| Specialties | Neurosurgery, Radiology |
What the Web Says
LumiNE US by Augmedit appears to be a mixed reality surgical navigation system that has garnered interest for its innovative approach to overlaying patient data directly onto the surgical field. While the technology is seen as promising for enhancing precision and reducing cognitive load, its novelty means that widespread, in-depth physician reviews are still emerging, with some early adopters highlighting its potential.
Overall: PositiveStrengths
- Enhanced surgical precision through direct data overlay
- Potential to reduce cognitive load for surgeons
- Innovative use of mixed reality in surgery
- Improved spatial understanding of patient anatomy
- Real-time visualization of critical information
- Potential for better training and education
Limitations
- Limited widespread adoption and long-term studies
- High initial cost of implementation
- Steep learning curve for some users
- Potential for technical glitches or calibration issues
- Dependency on robust IT infrastructure
- Lack of extensive independent physician reviews currently available
Based on reviews from: Augmedit Website, Medical Technology News Sites, Surgical Journals (early studies), Healthcare IT Publications, Tech Review Sites (limited specific product reviews)
Last updated: 2026-07-17
Ratings & Reviews
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Press & Coverage
Augmedit
LumiNE US Software Receives FDA Clearance for Surgical Planning - Augmedit
Augmedit announced that its LumiNE US software received FDA clearance for surgical planning, enabling medical professionals to convert 2D patient imaging into 3D models for enhanced visualization. The software integrates Augmented Reality (AR) and Artificial Intelligence (AI) to aid in surgical preparation, specifically for previously diagnosed conditions, and is not intended for diagnostic use.
2024-09
RadAI Slice
LumiNE US; Lumi | FDA Radiology AI Device - X-ray Interpreter
This article details the FDA clearance (K240094) for LumiNE US, a visualization software by Augmedit B.V. designed for neurosurgical planning. It converts 2D MRI and CT images into 3D models using AI-based segmentation and enables AR visualization via head-mounted displays to assist in understanding brain tumors and anatomy before surgery.
2024-09
accessdata.fda.gov
510(k) Premarket Notification - K240094
The FDA's 510(k) premarket notification for LumiNE US (K240094) outlines its intended use as a software device for visualizing medical images to provide insights into anatomy and pathology for surgical treatment preparation. It specifies the conversion of 2D patient imaging into 3D models and visualization via augmented reality, with a clear statement that images are for informational purposes only and not diagnostic use.
2024-09
MDPI
Augmenting Reality in Spinal Surgery: A Narrative Review of Augmented Reality Applications in Pedicle Screw Instrumentation - MDPI
This narrative review explores the current applications, benefits, and challenges of AR technology in spinal surgery, specifically focusing on its impact on surgical accuracy and patient outcomes. It highlights significant improvements in surgical precision, reduced complications, enhanced procedural efficiency, and shortened learning curves for surgeons.
2024-09
PubMed
Extended reality in the changing landscape of cranial neurosurgery: Role of image fusions and connectomics in precision and safety - PubMed
This article discusses the adoption of Extended Reality (XR) technologies, including augmented reality (AR), virtual reality (VR), and mixed reality (MR), in cranial neurosurgery to enhance visualizations for surgeons. XR has been integrated into neurosurgery for preoperative rehearsals, surgical simulation, and intraoperative augmentation, improving precision and safety.
2025-09
Augmedit
Augmedit Closes Seed Investment Round
Augmedit, a Dutch startup specializing in Augmented Reality software for surgeons, successfully closed a seed investment round of over u20ac1M. The funding, from Dutch and Swiss investors and US-based Revere Partners, will be used for CE certification and FDA clearance of its neurosurgery products and to expand its technology to other high-impact indications.
2022-11
Silicon Canals
Amsterdam-based medical AR startup Augmedit raises u20ac1M+ Seed funding; also secures u20ac1.7M from EIC - Silicon Canals
Amsterdam-based Augmedit, an AR medical software company, secured over u20ac1M in seed funding from a consortium of investors and an additional u20ac1.7M in non-dilutive funding from the EIC Accelerator program. The funds are earmarked for obtaining CE certification and FDA clearance for its neurosurgery products, as well as scaling its technology for broader applications in Europe and the US.
2022-11
Augmedit
News and Publications - Augmedit
Augmedit's news and publications page highlights several key milestones, including the FDA clearance of LumiNE US in September 2024 and the CE approval of LumiNE Elite in January 2026. It also features publications in medical journals such as Operative Neurosurgery and mentions their participation in the 32nd Annual iSMIT Congress.
2026-01
Videos
Product demos, reviews, and walkthroughs for LumiNE US.
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Frequently Asked Questions
LumiNE US is an FDA-cleared software designed for surgical planning, primarily for neurosurgeons and other qualified medical professionals. It converts 2D MRI and CT scans into interactive 3D models using AI-based segmentation, which can then be visualized via Augmented Reality (AR) using head-mounted displays to enhance insights during surgical preparation.
LumiNE US has received FDA clearance for use in surgical planning, indicating it meets specific regulatory standards for medical devices. The software utilizes AI-based algorithms for semi-automatic segmentation of anatomical structures and pathologies, and it's crucial that such systems adhere to robust data privacy and security protocols, like HIPAA, to safeguard sensitive patient information.
While LumiNE US offers a unique combination of AI-driven 3D modeling and AR visualization for surgical planning, other clinical decision support tools exist that aid in diagnostics and treatment recommendations. These can range from traditional evidence-based reference systems like UpToDate to other AI-powered imaging and diagnostic platforms, though their specific functionalities may differ.
Specific pricing details for LumiNE US are not publicly available, but healthcare AI solutions generally employ various pricing models, including subscription fees, usage-based models, or hybrid approaches. The cost of implementing AI in healthcare can vary significantly based on complexity, integration needs, and ongoing maintenance, with advanced solutions often requiring substantial investment.
LumiNE US is explicitly intended for the preparation phase of surgery and not for diagnostic purposes, meaning it aids in planning for previously diagnosed conditions. Like all AI tools, its segmentation algorithms are based on trained data, which can carry inherent biases or limitations in performance with diverse patient populations or rare pathologies.
Non-clinical testing demonstrated that LumiNE US software performs as intended with high accuracy of semi-automatic segmentation compared to manual segmentation by clinical experts. The segmentation algorithm showed non-inferior accuracy on a diverse US test dataset, meeting defined Dice similarity and Hausdorff distance metrics.
LumiNE US is designed to convert 2D MRI and CT scans into 3D models, implying integration with imaging systems like PACS for data input. While specific EHR integration details are not fully outlined, seamless integration with existing clinical workflows is a critical factor for the effective adoption of AI tools in healthcare.
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| Last Verified: 2026-04-17 | First Added: 2026-04-17