This Phase 1 study is a detailed assessment of the feasibility and costs of, and potential barriers to, selling Flat Panel X-ray Source ('FPS' or 'Distributed Array) in to the market, probably via an Original Equipment Manufacturer (OEM).
Crucial to opening up a new market, this design/ architecture must be able to be
a) independent of the X-ray detector manufacturers (‘vendor-neutral’);
b) demonstrate a compelling clinical advantage in an area of significant clinical interest;
c) demonstrate an economic advantage to OEMs and Hospitals; and,
d) show that the remainder of the ecosystem (image management infrastructure) can remain as-is to avoid barriers to entry.
As part of this we have conducted research in to technical issues to drive the development pathway:
a) Determine the dominant clinical studies that are routinely performed and how tomosynthesis could offer enhanced clinical insight for the dominant studies.
b) Confirm that the technology can meet the clinical needs in terms of image quality, for (at least) the dominant studies and ideally (materially) all studies typically performed including: i) Energy ranges (must be in the range 20-120keV); ii) Flux requirement; iii) Susceptibility to motion artefacts (blurring); and, iv) Potential issues on image reconstruction (metal artefacts etc.).
As part of this we have sought and obtained user involvement by:
a) Exploring, in detail, the preferences and variations (across EU and US), for imaging studies, such as relative use, approach to dose reduction, dose / image quality trade-off; and,
b) Seeking collaboration with a medical device OEM and clinical users to identify an application that requires the minimum technological innovation to demonstrate, in Phase 2, the potential for the wider, disruptive applications on the technology. For example Chest X-ray (CXR) for the identification of lung nodules, or orthopaedic imaging for the identification of occult hip fractures, that could be tested in Phase 2 on a phantom, and later in clinical trial.
