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Calcivis FDA Approval

CALCIVIS announces FDA filing of the Pre-Market Approval (PMA) application for its unique CALCIVIS imaging system

Edinburgh, November 2017 – CALCIVIS, a medical devices company focused on revolutionising the management of tooth decay and enabling preventive dentistry, announces that the FDA has accepted its CALCIVIS imaging system Pre-Market Approval (PMA) Application for substantive review. The filing of the PMA application to the FDA was made on 2 October 2017. Since then the FDA has conducted its initial administrative and limited scientific review and determined the submission to be complete. Subject to a successful outcome of the overall review process, the Company plans to launch its CALCIVIS imaging system in the USA in 2019.

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Calcivis FDA Approval

CALCIVIS announces FDA filing of the Pre-Market Approval (PMA) application for its unique CALCIVIS imaging system

Edinburgh, November 2017 – CALCIVIS, a medical devices company focused on revolutionising the management of…

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calcivis imaging systems

CALCIVIS announces positive results from PMA clinical study evaluating its unique CALCIVIS® imaging system

Edinburgh, 1 November 2017 – CALCIVIS, a medical devices company focused on revolutionising the management…

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calcivis bioluminescence

CALCIVIS launches new video

This video demonstrates how bioluminescence (light-emission) seen in nature, including in marine life such as…

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