New solution for fully automated analysis and reporting of routine musculoskeletal X-rays

Project Information

AutoRay

Grant agreement ID: 954221

DOI

10.3030/954221

Project closed

EC signature date 30 June 2020

Start date 1 July 2020

End date 31 March 2023

Funded under

• INDUSTRIAL LEADERSHIP - Innovation In SMEs

Total cost

€ 1 905 451,50

EU contribution

€ 1 333 816,05

Coordinated by

RADIOBOTICS APS
Denmark

Periodic Reporting for period 3 - AutoRay (New solution for fully automated analysis and reporting of routine musculoskeletal X-rays)

Reporting period: 2022-07-01 to 2023-03-31

Summary of the context and overall objectives of the project

Routine radiology services are facing challenges in having efficient workflows to deliver x-ray readings shortly after image acquisition – with patients waiting sometimes for days or weeks for the report. The volume of X-rays studies is still growing year after year with estimated more than 100 million studies of the musculoskeletal (MSK) x-ray studies annually in Europe alone. There is an urgent shortage of staff, causing potential delay in the treatment and decrease in the quality of care. Thus, there is an urgent need for solutions aiding in improving quality and reducing time spent on routine radiology services.
Radiobotics has developed comprehensive machine learning-based software tools that automatically analyses MSK x-rays and suggests a draft report.
The objective of the AutoRay project is to develop and validate a suite of msk x-ray products, while during market maturation of these and ensuring integration into hospital IT-systems, enabling access to the safe and novel technology for patients and clinicians.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

The work preformed in the project thus far have been centred around preparation of studies with clinical partners, which includes getting ethical approvals, getting collaboration contracts in place, and planning the protocols and trials. Also a lot of work has gone into preparation of the technical documentation needed for regulatory approvals for especially CE mark and quality management system, but also investigation into other regulatory pathways.
The first part of the software products have been developed, covering several anatomical parts and several clinical indications, and the algorithms have been matured for integration into hospital IT-systems, where several integrations have been prepared. Additionally some market research has been done and market demonstration planned with clinical sites in several countries and with several customer segments and profiles.

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

It is expected to have completed the multicenter clinical trials by the end of the project, that will be published as scientific dissemination and presented and conferences and used for regulatory submissions.
This will have an impact on the validation level expected for medical software, and will set the bar high for how this should be performed.

The impact will especially be on improving diagnostic accuracy and reducing time use on reporting on routine msk x-rays, which will have impact on hospitals, clinicians, patients and society. The actual quantifiable impact will be measured in our pilots and clinical demonstrations towards the end of the project.

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