Clinical Trial #1 Complete, US FDA 510k and NICE Recommendation Secured

Around 2007, the evaluation of our first five year multi-centre clinical trial came to fruition with our own in-house clinical specialists working alongside key centres in Newcastle, Gent, Baltimore and Washington. Help with the statistical analysis came from UK researcher Rose Baker and the technical skill of in-house software and hardware designers helped bring together a step change in patient diagnosis the system becoming the first ever (and still the only), CE registered (European) and FDA 510k registered (USA) diagnostic system for clinical burn assessment – an important milestone! Simultaneously, we wanted to seek independent verification that implementation of our technique was both clinically and cost beneficial so we worked with the National Institute of Health and Care Excellence, a UK Government body whose remit is to evaluate claims made by equipment and drug suppliers and make informed recommendations to the NHS, our UK Government health system. After evaluation, we received the verdict that it did make financial sense to implement the technology alongside the patient benefits on offer.