Periodic Reporting for period 2 - FLUAR (FLUAR - A novel solution for fluorescence-guided surgery based on augmented reality)
Reporting period: 2024-04-01 to 2025-03-31
Fluorescence-guided surgery (FGS) is increasingly vital in oncologic, vascular, and reconstructive procedures due to its ability to highlight critical structures using near-infrared (NIR) markers like indocyanine green (ICG). However, today’s FGS solutions consist of bulky towers with external cameras and screens. They introduce major bottlenecks such as subjective monitor-to-reality mapping, higher recurrence rates, workflow inefficiencies, and accessibility barriers. These create a critical gap in surgical accuracy, efficiency, and equity of care resulting in worse patient outcomes, increased healthcare costs, and strain on public health systems.
The FLUAR technology eliminates these limitations by introducing a disruptive Augmented Reality (AR) based surgical navigation system that visualizes ICG fluorescence data directly in the surgeon’s line of sight. The light-weight, wearable AR glasses eliminate the need for external monitors and large camera towers, providing a hands-free, real-time NIR visualization, and thereby improving precision and efficiency. The technology also enables wider adoption of advanced FGS procedures through high accessibility and lower running costs.
The technology is not yet commercially available and in the process of validation for later MDR CE and FDA certification.
FLUAR aims to significantly increase resection precisions, resulting potential reduction of the tumour reoccurrence rates. By reducing the procedure times, it will enable more surgeries with fewer surgeons, leading to faster critical care delivery for cancer and complex cases. By improved patient outcomes, it can lead to less tissue damage, fewer complications, and shorter hospital stays. By a reduction of the hardware costs, it can democratize access to cutting-edge surgical tools. By further accelerating the use and benefits of optical markers to for example nuclear markers, it can decrease the financial pressure on national systems and insurance.
The FLUAR technology eliminates these limitations by introducing a disruptive Augmented Reality (AR) based surgical navigation system that visualizes ICG fluorescence data directly in the surgeon’s line of sight. The light-weight, wearable AR glasses eliminate the need for external monitors and large camera towers, providing a hands-free, real-time NIR visualization, and thereby improving precision and efficiency. The technology also enables wider adoption of advanced FGS procedures through high accessibility and lower running costs.
The technology is not yet commercially available and in the process of validation for later MDR CE and FDA certification.
FLUAR aims to significantly increase resection precisions, resulting potential reduction of the tumour reoccurrence rates. By reducing the procedure times, it will enable more surgeries with fewer surgeons, leading to faster critical care delivery for cancer and complex cases. By improved patient outcomes, it can lead to less tissue damage, fewer complications, and shorter hospital stays. By a reduction of the hardware costs, it can democratize access to cutting-edge surgical tools. By further accelerating the use and benefits of optical markers to for example nuclear markers, it can decrease the financial pressure on national systems and insurance.
The FLUAR project set out to solve critical limitations in fluorescence-guided surgery (FGS) by creating a wearable AR headset capable of visualizing NIR markers like ICG directly in the surgeon’s line of sight. The main objectives were miniaturization of the NIR hardware for integration into AR glasses, the development of CV algorithms for the surgical guidance, technical and usability evaluations and guidance by expert end-users, and setting the stage for the subsequent clinical validation efforts.
The team finalized the hardware and software platform. Key breakthroughs included reducing the NIR imaging module for integration in a wearable AR headset. The system integrates see-through holographic optics, the key NIR, and onboard CV processing for the real-time visualization of tumour margins. A voice-controlled interface ensures hands-free use in sterile environments. Complete FLUAR systems were built for clinical use and key opinion leader feedback.
FLUAR has reached TRL 7–8, with a fully functional prototype. It demonstrated technical feasibility, clinical usability, and good alignment with regulatory requirements. The system eliminates the major bottlenecks of current FGS towers. The project delivered the first-of-its-kind AR headset for FGS, positioning FLUAR as a transformative tool for oncologic and reconstructive surgery, and setting the stage for MDR certification and commercial rollout.
FLUAR underwent EMC and safety testing, and usability and performance validation in various medical assessments. The project aligned all developments with ISO 13485 standards. Technical documentation for MDR CE certification was compiled. Clinical trials are now being prepared with top-tier medical institutions. Arspectra’s in-house QMS ensured process compliance, while the Luxembourg Institute of Health and clinical advisors guide the validation strategy.
The team finalized the hardware and software platform. Key breakthroughs included reducing the NIR imaging module for integration in a wearable AR headset. The system integrates see-through holographic optics, the key NIR, and onboard CV processing for the real-time visualization of tumour margins. A voice-controlled interface ensures hands-free use in sterile environments. Complete FLUAR systems were built for clinical use and key opinion leader feedback.
FLUAR has reached TRL 7–8, with a fully functional prototype. It demonstrated technical feasibility, clinical usability, and good alignment with regulatory requirements. The system eliminates the major bottlenecks of current FGS towers. The project delivered the first-of-its-kind AR headset for FGS, positioning FLUAR as a transformative tool for oncologic and reconstructive surgery, and setting the stage for MDR certification and commercial rollout.
FLUAR underwent EMC and safety testing, and usability and performance validation in various medical assessments. The project aligned all developments with ISO 13485 standards. Technical documentation for MDR CE certification was compiled. Clinical trials are now being prepared with top-tier medical institutions. Arspectra’s in-house QMS ensured process compliance, while the Luxembourg Institute of Health and clinical advisors guide the validation strategy.
FLUAR has delivered a disruptive advance in fluorescence-guided surgery (FGS) by creating the world’s first wearable AR headset capable of real-time, in-sight visualization of NIR markers such as indocyanine green (ICG). This innovation eliminates the need for traditional tower-based FGS systems in open surgeries with external cameras and displays, replacing them with a compact, ergonomic, and intelligent system tailored to the needs of surgeons.
The FLUAR headset integrates miniaturized NIR sensors and illumination systems, and embedded computer vision. It enables surgeons to see tumour margins and vascular structures directly in the sight on the surgical field. Compared to the current state-of-the-art of classic FGS towers, which requires costly, bulky systems and subjective monitor-to-patient mapping, FLUAR delivers a leap forward. It is lightweight, fully wearable, hands-free, and more accessible, offering a solution up to 3 times more cost-efficient and better suited to small and mid-sized hospitals.
FLUAR’s impact extends across clinical, operational, and economic domains. It has the potential to improve patient outcomes by reducing reoperation rates and complications, optimizes workflow by reducing cognitive and time burdens on surgeons, and lowers healthcare costs. Moreover, by removing the high capital and infrastructure barriers of traditional FGS, it democratizes access to precision surgery in under-resourced hospitals.
To ensure successful uptake and long-term impact, next steps consist of clinical validation efforts and final submission for MDR CE certification, the expansion of multicenter clinical trials to support broader adoption and reimbursement, strategic partnerships for commercialization, distribution, and market entry across the EU and US.
The FLUAR headset integrates miniaturized NIR sensors and illumination systems, and embedded computer vision. It enables surgeons to see tumour margins and vascular structures directly in the sight on the surgical field. Compared to the current state-of-the-art of classic FGS towers, which requires costly, bulky systems and subjective monitor-to-patient mapping, FLUAR delivers a leap forward. It is lightweight, fully wearable, hands-free, and more accessible, offering a solution up to 3 times more cost-efficient and better suited to small and mid-sized hospitals.
FLUAR’s impact extends across clinical, operational, and economic domains. It has the potential to improve patient outcomes by reducing reoperation rates and complications, optimizes workflow by reducing cognitive and time burdens on surgeons, and lowers healthcare costs. Moreover, by removing the high capital and infrastructure barriers of traditional FGS, it democratizes access to precision surgery in under-resourced hospitals.
To ensure successful uptake and long-term impact, next steps consist of clinical validation efforts and final submission for MDR CE certification, the expansion of multicenter clinical trials to support broader adoption and reimbursement, strategic partnerships for commercialization, distribution, and market entry across the EU and US.