EDINBURGH medical device company Calcivis is planning to launch its tooth decay imaging technology in the US in 2019 after its pre-market approval application was filed with the US Food and Drug Administration (FDA) in October.
Although the application is still subject to final approval, following an initial administrative and limited scientific review the FDA has determined the submission to be complete.
Calcivis chief executive Adam Christie said gaining approval in the US would be a “key step” that would allow the business to “maximise the commercial potential” of its technology.
“The in-depth market research that we have conducted with the dental community in the US gives us great confidence that there is a clear and significant market opportunity for the Calcivis imaging system, which allows the live visualisation of active tooth demineralisation,” Mr Christie said.
He added that the images produced by the device would “help to establish a new standard of preventive care in dentistry, which will benefit both dentists and their patients”.
In 2014 Calcivis raised £1.1 million to develop what was at that time its prototype technology.
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