ESA-backed innovation announces FDA clearance and live clinical trials in the UK.

UK-based company Adaptix, who developed a pioneering portable 3D X-ray imaging system with support from ESA’s Business Applications and Space Solutions (BASS) programme and the UK Space Agency, has announced two major milestones: FDA 510(k) clearance for its Adaptix Ortho350 Imaging System and the start of live clinical trials on patients at the Royal Devon University Healthcare NHS Foundation Trust in Exeter.

The Adaptix Ortho350 system delivers high-quality, low-dose 3D imaging for orthopaedic applications. It enables clinicians to obtain a stack of detailed diagnostic slices through the patient with a far higher level of accuracy than 2D X-rays.  Unlike CT scanners it is a portable solution which is particularly beneficial in remote or resource-limited settings, reducing delays and improving access to care.

The recent FDA clearance marks a critical step towards commercial deployment in the United States, validating the system’s safety and effectiveness. Meanwhile, clinical trials in Exeter are assessing its real-world performance, focusing on workflow efficiency and patient outcomes.

“This achievement demonstrates how space-derived technologies can deliver tangible benefits on Earth,” said Arnaud Runge, Technical Officer for ESA on the project. “We are very pleased to have supported this project from the early days and to see it achieve commercial and technical success across multiple markets. The low radiation dose and compactness of the system also mean we could even see Adaptix Ortho350 used in space in the future.”

Dr Paul Bate, CEO of the UK Space Agency said: “This progress shows the impact of collaboration between space and healthcare in driving innovation. By applying techniques originally developed for space, Adaptix is helping clinicians access faster, safer and more accurate diagnostics, directly benefiting patients and improving recovery pathways. We’re proud to have supported this journey through our partnership with ESA and look forward to seeing this technology improve patient outcomes across the UK and beyond.”

Sarah Small, CEO at Adaptix, said: “Securing this FDA 510(k) clearance represents a significant milestone for Adaptix in our mission to transform radiology. We already have a great deal of interest from healthcare providers and clinicians and are looking forward to delivering “3D-First” enhanced orthopaedic DT imaging across Primary Care, Intensive Care and Emergency Departments throughout the US and beyond.”

Adaptix’s imaging technology grew out of methods originally developed for space applications, ensuring compliance with stringent healthcare standards while maintaining portability and cost-effectiveness. It is already in use across the veterinary and non-destructive testing sectors and has also delivered positive results in human cadaver trials. The trial in Exeter is focusing on patients with inflammatory arthritis and will evaluate the performance of the Adaptix 3D imaging technology when compared to traditional 2D X-rays, focusing on three main areas: diagnostic potential, effective measurement of joint space and evaluation of bone density.

“Up to 30% of people with early rheumatoid arthritis are missed when diagnosed using 2D X-rays, but more-detailed 3D imaging – such as MRI and CT scans – is expensive and waiting lists can be long,” said Dr. Siân Phillips, Chief Medical Officer at Adaptix. “The compact design and lower radiation and power requirements of the Adaptix Ortho350 make 3D imaging much more accessible for clinicians and patients alike. These new trials mark an exciting new stage of our journey, not only delivering a clinical assessment of its effectiveness when compared to traditional 2D X-ray modalities, but also proves our range of clinical use cases from diagnostics to assessing disease progression.”

With regulatory approval secured and clinical trials underway, Adaptix is now preparing for commercial rollout in the US, paving the way for a new era of accessible diagnostic imaging worldwide. Looking ahead, CE marking for the system is also in progress, opening the door for commercialisation across Europe in 2026.

At this week’s Council Meeting at Ministerial Level (CM25) in Bremen, ESA Member States formally approved the new ACCESS programme, ensuring that European businesses will continue to benefit from the growth, innovation and dynamism brought by the commercialisation of space.

As part of the combined budget of €22.3 billion agreed for ESA by the Member States, Associate Members and Cooperating States, a total of €306 million has been agreed for ACCESS. This comprises €169 million subscription to ScaleUp and €137 million subscription to Business Applications and Space Solutions (BASS). As the flagship commercialisation programme from ESA, ACCESS will accelerate the commercialisation and competitiveness of the European space sector, in line with ESA’s Strategy 2040.

The context for CM25 is a complex one, set against a volatile backdrop of geopolitical instability, rapid technological change and unprecedented access to space.  As ESA Director General outlined earlier this week, “CM25 is more than just another Ministerial, it is a moment of radical decision-making,” and the investment in ACCESS reflects a wider European commitment to space, and recognition of the urgent need for Europe to strengthen its presence in the global space market.

ACCESS will continue to deliver support through the established ScaleUp and BASS elements. It offers enhanced financial, business and technical support for ideation, incubation, acceleration and market deployment of innovative products and services across the space value chain. It connects businesses, investors, suppliers and potential customers in space markets and the wider economy for the benefit of Europe.

New opportunities for European industry

The investment from the Member States this week means that the ScaleUp and BASS elements, as part of ACCESS, will continue to support Europe’s space sector.  For ScaleUp this means new and renewed BICs and Phi-Labs, and improved dealflow through Marketplace. For BASS this means new thematic campaigns tuned to the priorities of the Member States, additional and improved funding structures to facilitate innovation and growth, and the expansion of activities across all sectors, including safety and security.

Find out more about ACCESS

In the rail industry, regular maintenance, renewals and upgrades are vital to maintain infrastructure and ensure the reliability of the rail network. These essential works are often carried out in hazardous environments where even minor errors can significantly impact safety and project efficiency. 

UK company Tended has developed a geospatial system, known as the Digital Worksite, under ESA’s Business Applications and Space Solutions (BASS) Programme, with the support of the UK Space Agency, to address safety challenges in rail. 

With the close proximity of rail lines, complex worksites and human error, workers can lose situational awareness when placing protection equipment, stray onto live railway infrastructure or place the equipment in the wrong place or on the wrong line. This can lead to trains being stopped or colliding with the equipment, causing damage and lengthy network delays.

There are also high costs associated with infrastructure damage; for example, the costs associated with plant or machinery travelling through incorrectly set points is estimated at £250,000 per incident by the Rail Safety and Standards Board (RSSB).

Tended’s Digital Worksite moves beyond conventional and human-reliant practices, such as diagrams, paper-based plans, two-way communication and physical barriers, for managing worksites. The solution provides unrivalled worksite visibility to reduce the risk of human error and allow for the early identification of unsafe events to significantly enhance safety and efficiency.

Partnering with RTKFnet, the utilisation of Satellite Navigation systems like RTK (Real Time Kinematics) was integral to the success of the solution, enabling unprecedented real-time, centimetre-level accuracy of the position of people, vehicles and assets. Satellite Earth Observation Imagery has also supported the mapping of digital worksites where accurate maps are not usually available. This space-enabled ‘digital twin’ helps mitigate human errors and provides unprecedented oversight of live operations.

It enables organisations to create virtual boundaries - geofences - for designated safe zones on their worksites and specify the location of safety equipment, ensuring everything is in the correct place before work begins. The system automatically generates a live online map displaying real-time locations and movements of critical assets and equipment with alerts for risks such as vehicles approaching critical infrastructure or speed limits exceeded. This reduces the need for frequent two-way communication and enables early identification of unsafe events. Positioning devices worn by workers alert them the moment they exit safe work limits, notifying them to move back to safety and helping to prevent them from accessing open lines.

Prior to this project, Tended had a small presence in the rail sector, but working with ESA has proved to be game-changing in terms of progress and momentum, both for Tended and the rail industry. During their ESA pilot, Tended successfully demonstrated the system over 9,000 operational hours across live worksites, building confidence amongst procurement and safety teams. The pilot project exceeded KPIs and using the Net Promoter Score (NPS) metric, achieved a remarkable 63%, where the industry standard NPS is 36%.

Independent analysis suggests the adoption of the Digital Worksite not only dramatically improves worker safety but could also deliver up to £60 million per year in efficiency savings across the UK rail network.

"We are pleased to have supported the Digital Worksite project, which is improving the safety and efficiency of rail maintenance and infrastructure” said Enrico Spinelli, Applications Engineer at ESA. “This project has potential for wide-scale adoption across the industry, saving lives and increasing efficiency and is already enjoying remarkable commercial success.”

Dr Craig Brown, Investment Director at the UK Space Agency, said: “Space data and services provide a huge opportunity to improve safety and operational efficiency across many different sectors, and this is a clear demonstration of using space in an innovative way to deliver those benefits. The Digital Worksite showcases how satellite positioning and imagery can transform rail maintenance into a safer, smarter, and more responsive environment. By turning worksites into intelligent ecosystems, this project not only addresses long-standing safety challenges but also sets a new benchmark for operational excellence across infrastructure and transport.”

Leo Scott Smith, CEO and Founder at Tended said: "The ESA BASS programme has been invaluable, offering significant benefits to both our company and the broader rail industry across the UK and Europe. ESA's support in developing this safety innovation, through access to crucial space-based assets, has been instrumental in achieving the high accuracy and realistic representation of live rail environments. ESA has been pivotal in our journey in ensuring people stay safe on the rail network, providing expertise and resources that have accelerated the development and deployment of this important safety innovation."

The success of the Digital Worksite has set the foundation for industry-wide transformation and the system generated £1.28 million in annual revenue during project pilots. A four-year contract has been agreed for the Network Rail Wales route with additional contracts secured with Siemens Mobility, SPL Powerlines and others across Europe. This commercial success heralds a new era of rail safety for those working in safety-critical rail environments across Europe.