Axial3D Insight
by Axial Medical Printing Limited
· Based in United Kingdom →
— Transforming healthcare through AI-driven 3D medical imaging and patient-specific solutions.
Contact for pricing
Regulatory Status Disclosed
Overview
Axial3D INSIGHT™ is a user-friendly, cloud-based platform that simplifies the process of converting 2D medical imaging data, such as CT and MRI scans, into precise 3D digital and physical models. Leveraging AI algorithms and advanced machine learning techniques, the platform automates the traditionally time-consuming task of manual or semi-manual image segmentation. This enables healthcare professionals to easily view, analyze, and customize these models for enhanced surgical planning, patient communication, and personalized patient care. The platform supports the production of 3D digital files (like mesh or STL files) and 3D printed anatomical models, made with compatible 3D print technology. Axial3D INSIGHT™ is designed to integrate into existing ecosystems, supporting scalable patient-specific workflows across organizations, including connecting segmentation, planning, navigation, and robotic workflows. The service is fully managed, hosted in the UK, and includes full workflow and case management support, with expert assistance available for complex cases.
Reviewed by Pouyan Golshani, MD — Interventional Radiologist
Key Features
- AI-driven medical image segmentation
- Conversion of 2D DICOMs (CT, MRI) to 3D models
- Cloud-based platform for accessibility
- 3D visualization for surgical planning
- Generation of 3D print-ready files (STL, Mesh)
- Production of physical 3D anatomical models
- Full workflow and case management support
- Integration with PACS and Image Exchange Portals
- Data security with anonymization, encryption, and access controls
- User-friendly and intuitive interface
Use Cases
- Pre-surgical planning and simulation
- Patient communication and education
- Design of personalized medical devices and surgical kits
- Diagnostic support (in conjunction with other tools)
- Medical research and development
- Robotic surgery planning and navigation
What Physicians Need to Know
DICOM Support & Standards
Axial3D Insight is a cloud-based service that converts DICOM imaging data into precise 3D digital and physical models. Axial3D actively participates in DICOM Working Group 17, contributing to open standards for 3D printing in healthcare, including the acceptance of STL encapsulation into DICOM standard (Supplement 205) for tracking 3D objects in PACS/VNA. The platform processes anonymized DICOMs and does not store Protected Health Information (PHI).
PACS Integration Method
Users can directly upload DICOM data or connect the platform with their PACS department. Axial3D is integrated with key image sharing networks, such as the UK's Sectra Image Exchange Portal (IEP) and the US's Nuance PowerShare Network, for secure DICOM transfer.
Reading Room Workflow Impact
The platform automates the conversion of 2D DICOM images into 3D visualizations and models, significantly reducing the time required for segmentation from hours to minutes or days per case. This automation enhances insights into patient pathology, improves patient communication, supports multidisciplinary team collaboration, and facilitates pre-surgical planning and simulation. Studies indicate an average reduction of 62 minutes in surgery time per case when utilizing 3D printed models. AI is designed to assist radiologists by reducing burnout, accelerating tasks, and providing actionable insights.
AI Model Architecture (deep learning approach)
Axial3D Insight is powered by AI-driven, machine learning (ML) algorithms and advanced machine learning techniques, leveraging an AWS cloud-based infrastructure for exceptional segmentation. These models analyze data to anticipate surgical risks, optimize treatment strategies, and rapidly identify anatomical structures, reducing manual segmentation effort. AxialML machine learning models undergo independent verification and validation before integration.
Processing Speed (per study)
The application of machine learning has reduced the segmentation process from 4-10 hours to a few minutes per printed model, aiming for near-instantaneous results. The conversion of scanned images to a print-ready file can be achieved in under one hour. Axial3D aims to produce and ship patient-specific 3D anatomical models within 48 hours. Improvements in their Order Management System have led to a 30% reduction in order processing time.
FDA Clearance Pathway (510k/De Novo)
Axial3D Insight has received FDA 510(k) clearance as a Class II medical device. Notably, Axial3D is the first image segmentation company to receive FDA clearance for a Predetermined Change Control Plan (PCCP) for its AI-driven segmentation software, allowing for continuous updates and enhancements to machine learning models without repeated FDA submissions.
Supported Modalities (CT/MRI/X-ray/US)
The platform supports the automated conversion of 2D DICOM images from CT and MRI scans. The output files and physical replicas are intended for treatment planning and diagnostic purposes in orthopedic trauma, orthopedic, maxillofacial, and cardiovascular applications.
Sensitivity & Specificity Data
Validation studies confirm the software's accurate image segmentation for 3D model creation, with radiologists and physicians affirming the utility and accuracy in clinical settings. A Clinical Segmentation Performance study, involving 3 radiologists reviewing 12 cases across various specialties, scored all cases within acceptance criteria using the RADPEER framework. An Intended Use validation study with 9 physicians reviewing 12 cases successfully validated the 3D models, demonstrating they met end-user needs and indications for use. The models are designed to meet micro-millimeter accuracy requirements.
RSNA/ACR Validation
Axial3D actively participates in the medical 3D printing community and attends events like RSNA, where their CTO has shared insights on AI-driven imaging workflows. The company's involvement aligns with efforts by RSNA and ACR to establish a joint 3D printing registry for collecting clinical data and demonstrating the value of this technology. The Clinical Segmentation Performance study utilized the ACR RADPEER framework for assessment.
Physician Tip
For complex cases where 2D imaging is insufficient, Axial3D Insight provides detailed 3D models that can significantly enhance surgical planning and patient communication, potentially reducing operative time. Integrate these models into multidisciplinary team discussions for improved collaborative decision-making. Remember to use the AI-generated outputs in conjunction with your expert clinical judgment and other diagnostic tools.
Axial3D Insight is a cloud-based platform designed for seamless integration into existing radiology workflows. It supports direct DICOM uploads and connections with PACS departments, leveraging secure image sharing networks. Its AWS-based architecture and FDA-cleared Predetermined Change Control Plan (PCCP) ensure a scalable, efficient, and continuously evolving solution for 3D medical modeling.
Details
| Category | Radiology & Imaging AI, Surgical AI |
| Pricing |
Contact for pricing
|
| Deployment | Cloud-based (AWS) |
| Compliance | |
| BAA Available | Unknown AI-estimated |
| HIPAA Compliant | Unknown AI-estimated |
| FDA Status |
1 AI-estimated Axial3D INSIGHT™ received FDA Class II clearance (K232841) on October 19, 2023, for its automated, AI-driven, cloud-based segmentation platform for orthopedic trauma, orthopedic, maxillofacial, and cardiovascular applications. This was the second FDA clearance for their segmentation platform, building on a predicate device (K222745). The device is intended for use in treatment planning and diagnostic purposes in conjunction with other diagnostic tools and expert clinical judgment. Axial3D also received a Predetermined Change Control Plan (PCCP) approval from the FDA on October 20, 2025, allowing for faster deployment of custom segmentation updates. |
| Integrations | |
| EHR | Not specified |
| Specialties | Neurosurgery, Orthopedics, Radiology |
Ratings & Reviews
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Press & Coverage
Axial3D
Leading the Way in AI-Driven Segmentation and Surgical Planning: Axial3D INSIGHTu2122 Receives PCCP Approval from the FDA
Axial3D announced that its AI-driven segmentation software, Axial3D INSIGHTu2122, received FDA clearance for a Predetermined Change Control Plan (PCCP), making it the first image segmentation company with this clearance and market fundamental patents covering AI/ML-enabled segmentation. This allows for continuous updates and enhancements to their machine learning models without repeated FDA submissions.
2025-10
TCT Magazine
Axial3D & GE HealthCare combine INSIGHT & oZTEo bone imaging applications to enhance 3D modelling services
Axial3D and GE HealthCare are collaborating to offer enhanced 3D modeling services by combining Axial3D INSIGHT with GE HealthCare's oZTEo bone imaging application, allowing for radiation-free 3D visualizations and printed anatomical models from MRI data. This partnership aims to reduce the need for additional CT scans and provide medical teams with valuable tools for informed consent and improved communication.
2025-11
HIRANI
August Company of the Month - Axial3D
Axial3D INSIGHTu2122 is highlighted as a secure, cloud-based service providing medical device companies and surgeons with instant access to patient-specific 3D models, processed using AI-generated segmentations. The article emphasizes its role in accelerating personalized care and supporting device planning and development.
2025-08
Axial3D
3D-Printed Brachial Plexus Model for Thoracic Outlet Syndrome - Axial3D
This case study, published in the 3D Printing in Medicine Journal, showcases a collaboration between Hospital for Special Surgery and Axial3D, utilizing GE HealthCare's MRI sequences and Axial3D INSIGHTu2122 for radiation-free, patient-specific 3D printed models of the brachial plexus. The integrated workflow enhances clinical decision-making and patient communication.
2025-07
Taylor & Francis Online (Journal of 3D Printing in Medicine)
Measuring the quality and impact of 3D medical printing in surgical planning, procedures and communications using product usefulness surveys - Taylor & Francis
This article discusses a usability survey co-designed with Axial3D to measure the impact of their 3D prints and Axial3D Insight software on surgical practice, finding high usefulness in pre-operative planning, clinical communications, and technological value. The software received FDA approval in July 2023 as a Class II medical device.
2024-04
MDPI (Journal of Clinical Medicine)
Perioperative Benefits of a 3D Printed Spine Biomodel in the Setting of Congenital Scoliosis Surgery - MDPI
This retrospective case review details the use of a patient-specific 3D-printed spine model, designed using the Axial3D Insightu2122 cloud-based platform, for congenital scoliosis surgery. The AI-assisted automated segmentation significantly reduced manual segmentation time, leading to faster model delivery and improved perioperative planning.
2024-08
Business Wire
Axial3D Receives FDA Clearance for Axial3D INSIGHT Medical Image Segmentation Platform
Axial3D announced it received FDA clearance for its automated, AI-driven, cloud-based segmentation platform, Axial3D INSIGHTu2122, for orthopedic trauma, orthopedic, maxillofacial, and cardiovascular applications. This marks a significant milestone for personalized patient care and is expected to boost production processes for medical device companies.
2023-07
Medical Device Network
Axial3D's cloud-based segmentation platform secures FDA approval
Axial3D's AI-driven, cloud-based medical image segmentation platform, Axial3D INSIGHT, has received FDA approval for various orthopedic, cardiovascular, and maxillofacial applications. This platform automates the conversion of 2D DICOM images into 3D visualizations and print-ready files, aiding medical device companies in scaling patient-specific programs.
2023-08
Videos
Product demos, reviews, and walkthroughs for Axial3D Insight.
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Frequently Asked Questions
Axial3D Insight is an AI-driven, cloud-based platform that converts 2D medical imaging data, such as CT and MRI DICOMs, into precise 3D digital and physical anatomical models. This technology enhances surgical planning by providing surgeons with detailed 3D visualizations for pre-operative practice, improved diagnostic accuracy, and better patient communication.
Axial3D Insight is FDA cleared (Class II 510(k)) for automated, AI-driven segmentation in orthopedic trauma, orthopedic, maxillofacial, and cardiovascular applications. The platform is also HIPAA and GDPR compliant, and holds ISO 13485 and ISO 27001 certifications, ensuring robust data security and quality management.
Axial3D Insight prioritizes data security by processing anonymized DICOMs and does not store Personally Identifiable Information (PII) or Protected Health Information (PHI). It employs strict access controls, encryption (TLS 1.3+, AES-256), multi-factor authentication, and is hosted on a secure AWS cloud infrastructure, aligning with HIPAA and GDPR regulations.
Axial3D Insight should be used as a complement to other diagnostic methods and expert clinical judgment, not as a standalone diagnostic tool. The accuracy and applicability of the output models are dependent on the quality of the original DICOM images and the specifics of each case. Additionally, physical 3D printed models are not intended for sterilization or use within a sterile field.
Axial3D Insight offers flexible pricing models, including per-model pricing, annual license fees, and pay-per-use options, with educational pricing and free trials also available. While specific costs can vary, the platform aims to reduce capital expenditures and save hours or days per case by automating segmentation, which can be more cost-effective than traditional manual or semi-manual methods.
Yes, several alternatives exist for 3D medical modeling and segmentation, including Invivo5, 3D Slicer, Simpleware, OsiriX MD, Materialise Mimics Care Suite, D2P (DICOM to PRINT), and Virtual Surgical Planning (VSP). These platforms also offer various capabilities for converting medical imaging data into 3D visualizations and models for surgical planning.
Axial3D Insight utilizes advanced AI algorithms and machine learning techniques to automate the segmentation of 2D DICOM images into accurate 3D models. The AI-generated segmentations are then verified by biomedical engineers to ensure high quality and consistency. The platform also has FDA clearance for a Predetermined Change Control Plan (PCCP), allowing continuous, verified improvements to its machine learning models.
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| Last Verified: 2026-04-17 | First Added: 2026-04-17