New medical device and consumable combination for the assessment and management of tooth decay
Calcivis, a medical devices company focused on revolutionising the management of tooth decay, today announces that its Calcivis® Caries Activity Imaging System has been granted a CE Mark in Europe. A CE Mark is required before a medical device can be marketed in the EU and a number of other countries and signifies that the manufacturer meets the requirements of European legislation.
The Calcivis® Caries Activity Imaging System is a sophisticated medical device and consumable combination designed to transform the assessment and management of dental caries (tooth decay). It involves a unique, proprietary bioluminescence approach combined with a specialised imaging device which allows accurate detection and visualisation of demineralisation by imaging free calcium ions at the tooth surface; a caries lesion which is actively demineralising is more likely to progress and lead to cavitation.
Adam Christie, CEO of Calcivis, said: "The granting of a CE Mark is a landmark for Calcivis. Our system will, for the first time, allow the real-time detection and visualisation of calcium ions released by demineralising caries lesions in routine dental practice. This has the potential to allow for tailored, rational, evidence-based treatment in line with dental best practice."
"We believe there will be significant demand for our technology and are now working towards full commercialisation."