Periodic Reporting for period 2 - makinG aUgmedit lumI stanDArd in NeurosurgiCal surgEry in 3D: GUIDANCE 3D (makinG aUgmedit lumI stanDArd in NeurosurgiCal surgEry in 3D: GUIDANCE 3D)
Período documentado: 2024-01-01 hasta 2025-05-31
Medical imaging solutions are 2D black & white scans which are used by surgeons for patient education, surgical planning and operations. This workflow is inaccurate and non-intuitive, leading to many preventable medical errors (MEs) and poor stakeholder collaboration. Such MEs are the third leading cause of death in the US. Statistics show that reduction of MEs in the EU would lead to the prevention of more than 750k harm-inflicting MEs per year, leading in turn to over 3.2 million fewer days of hospitalization, 260k fewer incidents of permanent disability, and 95k fewer deaths per year. It is estimated that from these data, about 20% are caused by surgical errors.
Medical imaging has barely improved in the past decades. Most of the medical errors result from the fact that health professionals do not have access to proper visual tools during complicative interventions. In neurosurgery, for example, surgeons have to look away from the patient for extremely delicate navigation, which, clearly, complicates such intricate surgeries even further. This is true for many other surgical fields as well. New imaging hardware are extremely expensive and complex and not affordable for many clinical centres. This demonstrably hampers understanding of the disease, which interferes with shared decision making, an increasingly important aspect in treatment planning.
Augmedit develops the Lumi Elite AR SaaS platform for medical specialists, 3DLabs and patients. Our core goals are to enable users to see more, understand better and communicate easier with the most competitively priced product on the market. Lumi Elite for the first time enables intuitive intraoperative 3D guidance using AR which solves bottlenecks for surgeons during interventions, thereby reducing medical errors. Simulations of intervention strategies aid in preparation and planning. 2D scans are automatically converted into a 3D hologram and stored in our cloud. Relevant anatomical structures are automatically segmented using AI. All stakeholders are connected throughout the workflow with seamless AR collaboration. We enable shared decision making with intuitive and easy-to-use functionality. This holographic experience accelerates the insights of stakeholders, thereby improving the whole clinical workflow and outcome of patients: 1 hologram is worth a 1000 scans.
www.augmedit.com
Medical imaging has barely improved in the past decades. Most of the medical errors result from the fact that health professionals do not have access to proper visual tools during complicative interventions. In neurosurgery, for example, surgeons have to look away from the patient for extremely delicate navigation, which, clearly, complicates such intricate surgeries even further. This is true for many other surgical fields as well. New imaging hardware are extremely expensive and complex and not affordable for many clinical centres. This demonstrably hampers understanding of the disease, which interferes with shared decision making, an increasingly important aspect in treatment planning.
Augmedit develops the Lumi Elite AR SaaS platform for medical specialists, 3DLabs and patients. Our core goals are to enable users to see more, understand better and communicate easier with the most competitively priced product on the market. Lumi Elite for the first time enables intuitive intraoperative 3D guidance using AR which solves bottlenecks for surgeons during interventions, thereby reducing medical errors. Simulations of intervention strategies aid in preparation and planning. 2D scans are automatically converted into a 3D hologram and stored in our cloud. Relevant anatomical structures are automatically segmented using AI. All stakeholders are connected throughout the workflow with seamless AR collaboration. We enable shared decision making with intuitive and easy-to-use functionality. This holographic experience accelerates the insights of stakeholders, thereby improving the whole clinical workflow and outcome of patients: 1 hologram is worth a 1000 scans.
www.augmedit.com
Over the course of the project, we have successfully developed, validated, and prepared for market the LumiNe Elite augmented reality surgical navigation platform. The main achievements include:
Finalized and Validated a Market-Ready Product: We have delivered a complete, segmentation-driven AR platform for neurosurgical planning and guidance, achieving a final TRL of 8.
Generated Robust Clinical Evidence: We successfully completed a multi-center, randomized controlled phantom study which demonstrated that AR-guidance is superior to the conventional freehand technique for EVD placement. We also completed a clinical study confirming our registration accuracy is non-inferior to the current gold-standard neuronavigation systems.
Achieved Key Regulatory Milestones: We obtained ISO 27001 and NEN 7510 certifications for information security. Crucially, we also successfully obtained FDA 510(k) clearance for our core segmentation module, enabling market access in the United States.
Established a Strong IP Position: We secured a granted US patent for our core spatial mapping methodology.
Demonstrated Economic Value: We completed a formal Health Technology Assessment (HTA) which provides quantifiable evidence that our platform delivers significant per-case cost savings for hospitals.
Finalized and Validated a Market-Ready Product: We have delivered a complete, segmentation-driven AR platform for neurosurgical planning and guidance, achieving a final TRL of 8.
Generated Robust Clinical Evidence: We successfully completed a multi-center, randomized controlled phantom study which demonstrated that AR-guidance is superior to the conventional freehand technique for EVD placement. We also completed a clinical study confirming our registration accuracy is non-inferior to the current gold-standard neuronavigation systems.
Achieved Key Regulatory Milestones: We obtained ISO 27001 and NEN 7510 certifications for information security. Crucially, we also successfully obtained FDA 510(k) clearance for our core segmentation module, enabling market access in the United States.
Established a Strong IP Position: We secured a granted US patent for our core spatial mapping methodology.
Demonstrated Economic Value: We completed a formal Health Technology Assessment (HTA) which provides quantifiable evidence that our platform delivers significant per-case cost savings for hospitals.
This project provides concrete evidence that supports key EU policy priorities for digital transformation and industrial competitiveness.
Our main policy-relevant outcome is the quantifiable economic evidence generated by our Health Technology Assessment (HTA). The HTA provides a clear model demonstrating that the adoption of our digital health technology leads to significant cost-effectiveness and per-case savings for European healthcare systems. This directly supports EU policy goals related to healthcare sustainability and efficiency.
Furthermore, by successfully navigating the complex US regulatory process to achieve FDA 510(k) clearance and by securing a granted US patent, our project demonstrates that an EU-based SME can develop a world-leading deep-tech medical device and compete on a global scale. This serves as a policy-relevant example of the EU's capacity for innovation and its ability to create high-value technological assets.
Based on our experience, our main policy message is to encourage the continued streamlining of regulatory pathways for software-based medical devices and to foster support mechanisms for the international scale-up of high-potential EU MedTech SMEs.
Our main policy-relevant outcome is the quantifiable economic evidence generated by our Health Technology Assessment (HTA). The HTA provides a clear model demonstrating that the adoption of our digital health technology leads to significant cost-effectiveness and per-case savings for European healthcare systems. This directly supports EU policy goals related to healthcare sustainability and efficiency.
Furthermore, by successfully navigating the complex US regulatory process to achieve FDA 510(k) clearance and by securing a granted US patent, our project demonstrates that an EU-based SME can develop a world-leading deep-tech medical device and compete on a global scale. This serves as a policy-relevant example of the EU's capacity for innovation and its ability to create high-value technological assets.
Based on our experience, our main policy message is to encourage the continued streamlining of regulatory pathways for software-based medical devices and to foster support mechanisms for the international scale-up of high-potential EU MedTech SMEs.